(57 days)
Not Found
No
The summary describes a standard ultrasound system with various imaging modes and signal processing capabilities, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an ultrasound diagnostic system intended for diagnostic clinical applications, not therapeutic ones. Its description focuses on imaging and analysis of reflected echoes rather than providing any form of treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic ultrasound evaluation," and the "Device Description" section refers to it as an "ultrasound diagnostic system."
No
The device description explicitly lists hardware components such as ultrasound transducers, a computer system, and a video monitor, indicating it is a hardware-based ultrasound system with associated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The HI VISION Ascendus is an ultrasound diagnostic system. It uses ultrasound waves to create images of internal body structures. This is an in vivo diagnostic method, meaning it is performed within the living body.
- Intended Use: The intended use clearly states "diagnostic ultrasound evaluation" of various anatomical sites. This involves imaging the body directly, not analyzing samples taken from the body.
- Device Description: The components described (transducers, computer system, monitor) are typical of an ultrasound machine, not an IVD device.
- Lack of IVD-Specific Information: There is no mention of analyzing biological samples, reagents, or any other elements associated with in vitro testing.
Therefore, the HI VISION Ascendus is an in vivo diagnostic device, specifically an ultrasound system, and does not fall under the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Trans-esophageal (Cardiac) - Adult/Pediatric, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.
The modes of operation of the HI VISION Ascendus are B mode, M mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Dual Doppler mode, CFI mode (Color Flow Image), Amplitude Dopper (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real-time Virtual Sonography, Real-time Tissue Elastography and Shear Wave Measurement.
Product codes
IYN, IYO, ITX
Device Description
An ultrasound diagnostic system with the following features:
- Ultrasound transducer(s) = to generate the transmitted ultrasound energy and detect the reflected echoes O
- O Ultrasound transducer accessories (standard and optional) - to maximize functional usage of transducer(s) in various modes of operation
- O A computer system - to control the transducer and analyze the signals resulting from the reflected echoes
- o A video monitor with optional image recorder - to display the computed image or derived Doppler data
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Cardiac, Intra-operative, Trans-esophageal (Cardiac), Fetal, Pediatric, Small Organ, Peripheral vessel, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic.
Indicated Patient Age Range
Adult/Pediatric. For Adults and Pediatric patients.
Intended User / Care Setting
trained personnel (doctor, sonographer, etc.)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: No new hazards were identified with the subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.
Clinical testing: None required
Conclusions: The HI VISION Ascendus Diagnostic Ultrasound scanner is substantially equivalent in safety and effectiveness to the predicate device(s);
- The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging and fluid flow analysis.
- The subject and predicate device(s) have the same gray scale and Doppler capabilities.
- The subject and predicate device(s) have the same essential technology for imaging, Doppler functions, and signal processing.
- The subject and predicate device(s) have acoustic level below the Track 3 FDA limits.
- The subject and predicate device(s) are manufactured in accordance to FDA 21 CFR 820 Quality System Regulations.
- The subject and predicate device(s) are designed and manufactured to the same electrical and physical safety standards.
- The subject and predicate device(s) are manufactured with materials that have been tested in accordance to ISO 10993-1; all biocompatibility testing has been conducted in accordance to each component material characterization, type of body contact, and duration contact risk profile.
- The subject and predicate device(s) are designed to be re-usable and provide instructions for cleaning. disinfection, and sterilization in the Ultrasound system and transducer manuals.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and three human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2016
Hitachi Aloka Medical America, Inc. % Ms. Angela Van Arsdale RA/QA Manager 10 Fairfield Blvd. WALLINGFORD CT 06492
Re: K153421
Trade/Device Name: HI VISION Ascendus Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: December 10, 2015 Received: December 11, 2015
Dear Ms. Van Arsdale:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K153421
Device Name HI VISION Ascendus
Indications for Use (Describe)
HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Trans-esophageal (Cardiac) - Adult/Pediatric, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.
The modes of operation of the HI VISION Ascendus are B mode, M mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Dual Doppler mode, CFI mode (Color Flow Image), Amplitude Dopper (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real-time Virtual Sonography, Real-time Tissue Elastography and Shear Wave Measurement.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| ---------------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
HI VISION Ascendus System:
Transducer: All connectable probes
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined*
(Spec.) | Other** (Spec.) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----|----|-----|-----|------------------|----------------------|-----------------|
| General
(Track 1 only) | Ophthalmic | | | | | | | |
| Ophthalmic | Fetal | P | P | P | P | P | P | P |
| | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | Pb | Pb | Pb | | Pb | Pb | Pb |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | P | P | P | | P | P | P |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | Pc | Pd | Pd | Pd |
| | Neonatal Cephalic | P | P | P | P | P | P | P |
| Fetal Imaging &
Other | Adult Cephalic | P | P | P | P | P | P | P |
| | Trans-rectal | Pe | Pe | Pe | | Pe | Pe | Pe |
| | Trans-vaginal | Pf | Pf | Pf | | Pf | Pf | Pf |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | P | P |
| | Musculo-skel. (Superfic.) | P | P | P | | P | P | P |
| | Intra-luminal | | | | | | | |
| | Other (Spec.) | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| | Trans-esophageal (Card.) | Pg | Pg | Pg | Pg | Pg | Pg | Pg |
| | Other (Spec.) | | | | | | | |
| | | | | | | | | |
| Peripheral Vessel | Peripheral Vessel | P | P | P | P | P | P | P |
| | Other (Spec.) | | | | | | | |
| N= new indication P= previously cleared in K110673 | | | | | | | | |
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW,
TDI-B/B, TDI-B/M, TDI-B/PW, TDI-PW/PW | | | | | | | | |
| **Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, 4D Imaging, Omni Directional M mode, Wide View, Real Time Biplane,
Contrast Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography, Shear Wave Measurement. | | | | | | | | |
| Additional Comments: | | | | | | | | |
| Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | | |
| Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | | |
| Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | | |
| Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | | |
| Subscript "e": Includes imaging for guidance of trans-rectal biopsy. | | | | | | | | |
| Subscript "f": Includes managing for guidance of trans-vaginal biopsy. | | | | | | | | |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: __
4
System: HI VISION Ascendus
Transducer: EUP-B512
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** (Spec.) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | ||||||||
| Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Contrast Imaging, Real Time Virtual Sonography. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
5
System: HI VISION Ascendus
Transducer: EUP-B514
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | |||||
| (Spec.) | Other** (Spec.) | |||||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | ||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | Adult Cephalic | |||||||
| Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/CFM-B/PW | ||||||||
| ** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Virtual Sonography. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | ||||||||
| For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
6
System: HI VISION Ascendus
Transducer: EUP-B712
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other** (Spec.) | ||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | Adult Cephalic | |||||||
| Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| * Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW | ||||||||
| ** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Contrast Imaging, Real Time Virtual Sonography. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | ||||||||
| Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | ||||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | ||||||||
| For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
7
System: HI VISION Ascendus
Transducer: EUP-B715
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other** (Spec.) | ||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | Adult Cephalic | |||||||
| Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW | ||||||||
| ** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Contrast Imaging, Real Time Virtual Sonography. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
8
System: HI VISION Ascendus
Transducer: EUP-C511
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other** (Spec.) | ||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | Adult Cephalic | |||||||
| Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | P | P | P | P | P | P | ||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | |
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | P | P | P | P | P | P | |
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| * Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/CFM-B/PW | ||||||||
| ** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane, | ||||||||
| Contrast Imaging, Real Time Virtual Sonography. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
9
System: HI VISION Ascendus
Transducer: EUP-C514
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other** (Spec.) | ||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | Adult Cephalic | |||||||
| Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane, | ||||||||
| Contrast Imaging, Real Time Virtual Sonography. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
10
System: HI VISION Ascendus
Transducer: EUP-C524
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other** (Spec.) | ||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pc | Pc | Pc | Pc | Pc | Pc | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | Adult Cephalic | |||||||
| Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| * Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW | ||||||||
| ** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane, | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
11
System: HI VISION Ascendus
Transducer: EUP-C532
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** (Spec.) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Fetal Imaging & | ||||||||
| Other | Intra-operative (Spec.) | Pb | Pb | Pb | Pb | Pb | Pb | |
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | ||
| Neonatal Cephalic | P | P | P | P | P | P | ||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | P | P | P | P | P | P | |
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Real Time Tissue Elastography, Real Time Virtual Sonography. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | ||||||||
| Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | ||||||||
| Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis. | ||||||||
| Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | ||||||||
| Subscript "e": Includes imaging for guidance of trans-rectal biopsy. | ||||||||
| Subscript "f": Includes managing for guidance of trans-vaginal biopsy. | ||||||||
| Subscript "g": For Adults and Pediatric patients |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
12
System: HI VISION Ascendus
Transducer: EUP-C715
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other** (Spec.) | ||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | Adult Cephalic | |||||||
| Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| * Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW | ||||||||
| ** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane, | ||||||||
| Contrast Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography, Shear Wave Measurement. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
13
System: HI VISION Ascendus
Transducer: EUP-CC531
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other** (Spec.) | ||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | Adult Cephalic | |||||||
| Other | Trans-rectal | Pe | Pe | Pe | Pe | Pe | Pe | |
| Trans-vaginal | Pf | Pf | Pf | Pf | Pf | Pf | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Real Time Biplane, | ||||||||
| Contrast Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography, | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | ||||||||
| Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | ||||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
14
System: HI VISION Ascendus
Transducer: EUP-CC531S
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | ||
| Doppler | Combined* | |||||||
| (Spec.) | Other** (Spec.) | |||||||
| (Track 1 only) | (Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | Adult Cephalic | |||||||
| Other | Trans-rectal | Pe | Pe | Pe | Pe | Pe | Pe | |
| Trans-vaginal | Pf | Pf | Pf | Pf | Pf | Pf | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| * Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/CFM-B/PW | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Real Time Biplane, | ||||||||
| Contrast Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: ________________
15
System: HI VISION Ascendus
Transducer: EUP-CV524
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** (Spec.) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | ||||||||
| Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging, Omni Directional M mode | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: __
16
System: HI VISION Ascendus
Transducer: EUP-CV714
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** (Spec.) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | ||||||||
| Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging, Omni Directional M mode. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
17
System: HI VISION Ascendus
Transducer: EUP-CV724
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** (Spec.) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | P | P | P | P | P | P | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | ||||||||
| Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging, Omni Directional M mode. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: _______________
18
System: HI VISION Ascendus
Transducer: EUP-ES52E
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other** (Spec.) | ||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | Adult Cephalic | |||||||
| Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | P | P | P | P | P | P | P | |
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | ||||||||
| **Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. | |||||||
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: ________________
19
System: HI VISION Ascendus
Transducer: EUP-ES52M
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined*
(Spec.) | Other** (Spec.) | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------|--|
| General
(Track 1 only) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging &
Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Spec.) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Spec.) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (Spec.) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Card.) | P | P | P | P | P | P | P | |
| | Other (Spec.) | | | | | | | | |
| Peripheral Vessel | Peripheral Vessel | | | | | | | | |
| | Other (Spec.) | | | | | | | | |
| | N= new indication P= previously cleared in K110673 | | | | | | | | |
| | *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | | | | | | | | |
| | **Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode. | | | | | | | | |
| Additional Comments: | | | | | | | | | |
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | | |
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | | |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | | |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | | | | | | | | |
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | | | | | | | | |
| Subscript "g": | For Adults and Pediatric patients. | | | | | | | | |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
20
System: HI VISION Ascendus
Transducer: EUP-F334
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Combined*
General
Specific
Color
Other ** (Spec.)
B
M
PWD
CWD
(Track 1 only)
(Tracks I & III)
Doppler
(Spec.)
Ophthalmic
Ophthalmic
Fetal
Abdominal
Pb
Pb
Pb
Pb
Pb
Pb
Intra-operative (Spec.)
Intra-operative (Neuro.)
Laparoscopic
P
P
P
P
b
P
Pediatric
Pc
Рс
Рс
Рс
Рс
Рс
Small Organ (Spec.)
P
P
P
P
b
Neonatal Cephalic
b
Fetal Imaging &
Adult Cephalic
Other
P
P
P
P
P
P
Trans-rectal
P
P
P
P
P
P
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (Spec.)
Cardiac Adult
Cardiac
Cardiac Pediatric
Trans-esophageal (Card.)
Other (Spec.)
P
Peripheral Vessel
P
P
P
P
P
Peripheral Vessel
Other (Spec.)
N= new indication P= previously cleared in K110673
- Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW.
**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane.
Additional Comments:
Subscript "a":
Includes imaging tor guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis).
Subscript "b":
Includes imaging of organs and structures exposed during neurosurgery and laparoscopic procedures).
Subscript "c":
Includes thyroid, parathyroid, breast, scrotum, penis.
Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "d":
Subscript "e":
Includes imaging for guidance of trans-rectal biopsy.
Subscript "f":
Includes managing for guidance of trans-vaginal biopsy.
Subscript "g":
For Adults and Pediatric patients. | Clinical Application | | | | | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--|--|--|--|--|--|--|--|
| | | | | | | | | | |
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| | | | | | | | | | |
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| | | | | | | | | | |
| | | | | | | | | | |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: ________________
21
System: HI VISION Ascendus
Transducer: EUP-F531
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined*
(Spec.) | Other** (Spec.) |
|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----|----|-----|-----|------------------|----------------------|-----------------|
| General
(Track 1 only) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | P | P | P | | P | P | P |
| | Intra-operative (Spec.) | Pb | Pb | Pb | | Pb | Pb | Pb |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Spec.) | Pc | Pc | Pc | | Pc | Pc | Pc |
| | Neonatal Cephalic | P | P | P | | P | P | P |
| Fetal Imaging &
Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P |
| | Trans-vaginal | P | P | P | | P | P | P |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Card.) | | | | | | | |
| | Other (Spec.) | | | | | | | |
| Peripheral Vessel | Peripheral Vessel | P | P | P | | P | P | P |
| | Other (Spec.) | | | | | | | |
| | N= new indication P= previously cleared in K110673 | | | | | | | |
| | *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | | | | | | | |
| | ** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane. | | | | | | | |
| | | | | | | | | |
| Additional Comments: | | | | | | | | |
| Subscript "a":
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | | |
| Subscript "b":
Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | | | | | | | |
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | | | | | | | |
| Subscript "g":
For Adults and Pediatric patients. | | | | | | | | |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
22
HI VISION Ascendus System:
Transducer: EUP-L52
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** (Spec.) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | ||||||||
| Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | P | ||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | P | P | P | P | P | P | |
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane, | ||||||||
| Contrast Imaging, Real Time Tissue Elastography. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | ||||||||
| Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | ||||||||
| Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis. | ||||||||
| Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | ||||||||
| Subscript "e": Includes imaging for guidance of trans-rectal biopsy. | ||||||||
| Subscript "f": Includes managing for guidance of trans-vaginal biopsy. | ||||||||
| Subscript "g": For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: ________________
23
HI VISION Ascendus System:
Transducer: EUP-L53
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | |||||
| (Spec.) | Other** (Spec.) | |||||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | Other** (Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | Adult Cephalic | |||||||
| Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | P | ||
| Musculo-skel. (Superfic.) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | P | P | P | P | P | P | |
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| * Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | ||||||||
| ** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Tissue Elastography | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | ||||||||
| Subscript "b": | ||||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | ||||||||
| Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | ||||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. | |||||||
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: __
24
System: HI VISION Ascendus
Transducer: EUP-L53L
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Other** (Spec.)
Specific
Combined*
General
Color
B
M
PWD
CWD
(Tracks I & III)
(Track 1 only)
Doppler
(Spec.)
Ophthalmic
Ophthalmic
Fetal
P
P
P
P
P
P
Abdominal
Intra-operative (Spec.)
Intra-operative (Neuro.)
Laparoscopic
P
P
P
b
b
P
Pediatric
Small Organ (Spec.)
Рс
Рс
Рс
Pc
Pc
Pc
Neonatal Cephalic
Fetal Imaging &
Adult Cephalic
Other
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
P
P
P
P
P
P
Musculo-skel. (Convent.)
P
P
P
P
P
P
Musculo-skel. (Superfic.)
Intra-luminal
Other (Spec.)
Cardiac Adult
Cardiac
Cardiac Pediatric
Trans-esophageal (Card.)
Other (Spec.)
Peripheral Vessel
P
P
P
P
Peripheral Vessel
P
b
Other (Spec.)
N= new indication P= previously cleared in K110673
- Combination of each operating mode, B, M, PWD, and Color Dopler, B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW.
**Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Tissue Elastography
Additional Comments:
Subscript "a":
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis).
Includes imaging of organs and structures exposed during neurosurgery and laparoscopic procedures).
Subscript "b":
Subscript "c":
Includes thyroid, parathyroid, breast, scrotum, penis.
Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "d":
Subscript "e":
Includes imaging for guidance of trans-rectal biopsy.
Includes managing for guidance of trans-vaginal biopsy.
Subscript "f":
Subscript "g":
For Adults and Pediatric patients. | Clinical Application | | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--|--|--|--|--|--|--|--|
| | | | | | | | | | |
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Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
25
System: HI VISION Ascendus
Transducer: EUP-L54MA
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined*
(Spec.) | Other** (Spec.) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----|----|-----|-----|------------------|----------------------|-----------------|
| General
(Track 1 only) | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | Pa | Pa | Pa | | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | | Pd | Pd | Pd |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging &
Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | P | P |
| | Musculo-skel. (Superfic.) | P | P | P | | P | P | P |
| | Intra-luminal | | | | | | | |
| | Other (Spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Card.) | | | | | | | |
| | Other (Spec.) | | | | | | | |
| Peripheral Vessel | Peripheral Vessel | P | P | P | | P | P | P |
| | Other (Spec.) | | | | | | | |
| | N= new indication P= previously cleared in K110673 | | | | | | | |
| | *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | | | | | | | |
| | **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane, Real Time Tissue Elastography. | | | | | | | |
| Additional Comments: | | | | | | | | |
| | Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | |
| | Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | |
| | Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | |
| | Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | |
| | Subscript "e": Includes imaging for guidance of trans-rectal biopsy. | | | | | | | |
| | Subscript "f": Includes managing for guidance of trans-vaginal biopsy. | | | | | | | |
| | Subscript "g": For Adults and Pediatric patients. | | | | | | | |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: _______________
26
HI VISION Ascendus System:
Transducer: EUP-L65
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** (Spec.) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pc | Pc | Pc | Pc | Pc | Pc | ||
| Fetal Imaging & | ||||||||
| Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | P | ||
| Musculo-skel. (Superfic.) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | P | P | P | P | P | P | |
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane, Real Time Tissue Elastography | ||||||||
| Real Time Virtual Sonography. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: ________________
27
System: HI VISION Ascendus
Transducer: EUP-L73S
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** (Spec.) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | ||
| Fetal Imaging & | ||||||||
| Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | P | ||
| Musculo-skel. (Superfic.) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | P | P | P | P | P | P | |
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane, Contrast Imaging, Real Time Tissue | ||||||||
| Elastography, Real Time Virtual Sonography. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: ___
28
System: HI VISION Ascendus
Transducer: EUP-L74M
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined*
(Spec.) | Other** (Spec.) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|----|-----|-----|------------------|----------------------|-----------------|
| General
(Track 1 only) | Ophthalmic | | | | | | | |
| Ophthalmic | Fetal | | | | | | | |
| | Abdominal | Pa | Pa | Pa | | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | | Pd | Pd | Pd |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging &
Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | P | P |
| | Musculo-skel. (Superfic.) | P | P | P | | P | P | P |
| | Intra-luminal | | | | | | | |
| | Other (Spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Card.) | | | | | | | |
| | Other (Spec.) | | | | | | | |
| Peripheral Vessel | Peripheral Vessel | P | P | P | | P | P | P |
| | Other (Spec.) | | | | | | | |
| | N= new indication P= previously cleared in K110673 | | | | | | | |
| | *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | | | | | | | |
| | **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane, Contrast Imaging, Real Time Tissue
Elastography, Real Time Virtual Sonography. | | | | | | | |
| Additional Comments: | | | | | | | | |
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | |
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | | | | | | | |
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | | | | | | | |
| Subscript "g": | For Adults and Pediatric patients. | | | | | | | |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
29
HI VISION Ascendus System:
Transducer: EUP-L75
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other** (Spec.) | ||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | Adult Cephalic | |||||||
| Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | P | ||
| Musculo-skel. (Superfic.) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | P | P | P | P | P | ||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane, | ||||||||
| Real Time Tissue Elastography, Real Time Virtual Sonography. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
30
System: HI VISION Ascendus
Transducer: EUP-LV74
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** (Spec.) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pc | Pc | Pc | Pc | Pc | Pc | ||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | ||||||||
| Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | P | ||
| Musculo-skel. (Superfic.) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | P | P | P | P | P | P | |
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging, Omni Directional M mode, Real Time Tissue Elastography | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. | |||||||
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
31
System: HI VISION Ascendus
Transducer: EUP-053T
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other** (Spec.) | ||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | Pb | Pb | Pb | Pb | Pb | Pb | ||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | Adult Cephalic | |||||||
| Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| * Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | ||||||||
| ** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Contrast Imaging, Real Time Tissue Elastography. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
32
System: HI VISION Ascendus
Transducer: EUP-054J
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined*
(Spec.) | Other** (Spec.) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----|----|-----|-----|------------------|----------------------|-----------------|
| General
(Track 1 only) | Ophthalmic | | | | | | | |
| Ophthalmic | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Spec.) | Pb | Pb | Pb | | Pb | Pb | Pb |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging &
Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | P | P |
| | Musculo-skel. (Superfic.) | P | P | P | | P | P | P |
| | Intra-luminal | | | | | | | |
| | Other (Spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Card.) | | | | | | | |
| | Other (Spec.) | | | | | | | |
| | | | | | | | | |
| Peripheral Vessel | Peripheral Vessel | P | P | P | | P | P | P |
| | Other (Spec.) | | | | | | | |
| | N= new indication P= previously cleared in K110673 | | | | | | | |
| | *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | | | | | | | |
| | **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane, Real Time Tissue Elastography. | | | | | | | |
| Additional Comments: | | | | | | | | |
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | |
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | | | | | | | |
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | | | | | | | |
| Subscript "g": | For Adults and Pediatric patients. | | | | | | | |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: ________________
33
System: HI VISION Ascendus
Transducer: EUP-0732T
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** (Spec.) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | P | P | P | P | P | P | ||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | ||||||||
| Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, | ||||||||
| Contrast Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
34
System: HI VISION Ascendus
Transducer: EUP-OL334
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** (Spec.) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | P | P | P | P | P | P | ||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | ||||||||
| Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Contrast Imaging, Real Time Tissue Elastography. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | ||||||||
| Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | ||||||||
| Subscript "b": | ||||||||
| Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | ||||||||
| Subscript "c": | ||||||||
| Includes thyroid, parathyroid, breast, scrotum, penis. | ||||||||
| Subscript "d": | ||||||||
| Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | ||||||||
| Subscript "e": | ||||||||
| Includes imaging for guidance of trans-rectal biopsy. | ||||||||
| Subscript "f": | ||||||||
| Includes managing for guidance of trans-vaginal biopsy. | ||||||||
| Subscript "g": | ||||||||
| For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
35
System: HI VISION Ascendus
Transducer: EUP-R54AW-19, -33
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | | B | M | PWD | CWD | Color
Doppler | Combined*
(Spec.) | Other** (Spec.) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------|
| General
(Track 1 only) | Specific
(Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &
Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Card.) | | | | | | | |
| | Other (Spec.) | | | | | | | |
| Peripheral Vessel | Peripheral Vessel | | | | | | | |
| | Other (Spec.) | | | | | | | |
| | N= new indication P= previously cleared in K110673 | | | | | | | |
| | | | | | | | | |
| | *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | | | | | | | |
| | | | | | | | | |
| | **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Real Time Tissue Elastography. | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| Additional Comments: | | | | | | | | |
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | |
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | | | | | | | |
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | | | | | | | |
| Subscript "g": | For Adults and Pediatric patients. | | | | | | | |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
36
System: HI VISION Ascendus
Transducer: EUP-S50A
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other** (Spec.) | ||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | P | |
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa | |
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | |
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | Adult Cephalic | P | P | P | P | P | P | P |
| Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | P | P | P | P | P | P | P | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | P | P | P | P | P | P | P |
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| * Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW, | TDI-B/B, TDI-B/M, TDI-B/PW, TDI-PW/PW. | |||||||
| ** Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode, Contrast Imaging. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
37
HI VISION Ascendus System:
Transducer: EUP-S52
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other** (Spec.) | ||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | |
| Small Organ (Spec.) | Pc | Pc | Pc | Pc | Pc | Pc | Pc | |
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | Adult Cephalic | |||||||
| Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| * Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW, | ||||||||
| TDI-B/B, TDI-B/M, TDI-B/PW, TDI-PW/PW | ||||||||
| ** Amplitude Doppler (Color Flow Angiography), Tisue Doppler Imaging, Omni Directional M mode, Real Time Biplane. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. | |||||||
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: _______________
38
HI VISION Ascendus System:
Transducer: EUP-S70
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other** (Spec.) | |||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | ||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | P | ||
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | ||
| Small Organ (Spec.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | Adult Cephalic | P | P | P | P | P | P | P | |
| Other | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (Spec.) | |||||||||
| Cardiac Adult | P | P | P | P | P | P | P | ||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P | |
| Trans-esophageal (Card.) | |||||||||
| Other (Spec.) | |||||||||
| Peripheral Vessel | Peripheral Vessel | P | P | P | P | P | P | P | |
| Other (Spec.) | |||||||||
| N= new indication P= previously cleared in K110673 | |||||||||
| * Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW, | |||||||||
| TDI-B/B, TDI-B/M, TDI-B/PW, TDI-PW/PW | |||||||||
| ** Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode, Real Time Biplane, Contrast Imaging. | |||||||||
| Additional Comments: | |||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | ||||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | ||||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | ||||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | ||||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | ||||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | ||||||||
| Subscript "g": | For Adults and Pediatric patients |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: ________________
39
HI VISION Ascendus System:
Transducer: EUP-S72
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other** (Spec.) | ||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | P | P | P | |
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | |
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | |
| Fetal Imaging & | Adult Cephalic | |||||||
| Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | P | P | P | P | P | P | P | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW, | ||||||||
| TDI-B/B, TDI-B/M, TDI-B/PW, TDI-PW/PW | ||||||||
| **Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: _______________
40
HI VISION Ascendus System:
Transducer: EUP-S80
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined*
(Spec.) | Other** (Spec.) | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------|--|
| General
(Track 1 only) | Ophthalmic | | | | | | | | |
| Fetal Imaging &
Other | Fetal | P | P | P | P | P | P | P | |
| | Abdominal | P | P | P | P | P | P | P | |
| | Intra-operative (Spec.) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P | |
| | Small Organ (Spec.) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | P | P | P | P | P | P | P | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (Spec.) | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | |
| | Cardiac Pediatric | P | P | P | P | P | P | P | |
| | Trans-esophageal (Card.) | | | | | | | | |
| | Other (Spec.) | | | | | | | | |
| Peripheral Vessel | Peripheral Vessel | P | P | P | P | P | P | P | |
| | Other (Spec.) | | | | | | | | |
| | N= new indication P= previously cleared in K110673 | | | | | | | | |
| | *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW,
TDI-B/B, TDI-B/M, TDI-B/PW, TDI-PW/PW | | | | | | | | |
| | **Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, Omni Directional M mode, Real Time Biplane, Contrast Imaging. | | | | | | | | |
| Additional Comments: | | | | | | | | | |
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | | |
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | | |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | | |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | | | | | | | | |
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | | | | | | | | |
| Subscript "g": | For Adults and Pediatric patients. | | | | | | | | |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: _______________
41
System: HI VISION Ascendus
Transducer: EUP-U533
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other** (Spec.) | ||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | Adult Cephalic | |||||||
| Other | Trans-rectal | Pe | Pe | Pe | Pe | Pe | Pe | |
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| * Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Real Time Tissue Elastography, Real Time Virtual Sonography, | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. | |||||||
Prescription Use Only (per 21 CFR 801.109)
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42
System: HI VISION Ascendus
Transducer: EUP-V53W
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other** (Spec.) | ||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | ||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging & | Adult Cephalic | |||||||
| Other | Trans-rectal | Pe | Pe | Pe | Pe | Pe | Pe | |
| Trans-vaginal | Pf | Pf | Pf | Pf | Pf | Pf | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Card.) | ||||||||
| Other (Spec.) | ||||||||
| Peripheral Vessel | Peripheral Vessel | |||||||
| Other (Spec.) | ||||||||
| N= new indication P= previously cleared in K110673 | ||||||||
| * Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | ||||||||
| ** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Contrast Imaging, Real Time Tissue Elastography, | ||||||||
| Real Time Virtual Sonography. | ||||||||
| Additional Comments: | ||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | |||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | |||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | |||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | |||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | |||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
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System: HI VISION Ascendus
Transducer: EUP-V73W
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | Color | Combined* | Other** (Spec.) | |||||
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | ||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | |||
| Abdominal | |||||||||
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Spec.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging & | Adult Cephalic | ||||||||
| Other | Trans-rectal | Pe | Pe | Pe | Pe | Pe | Pe | ||
| Trans-vaginal | Pf | Pf | Pf | Pf | Pf | Pf | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (Spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Card.) | |||||||||
| Other (Spec.) | |||||||||
| Peripheral Vessel | Peripheral Vessel | ||||||||
| Other (Spec.) | |||||||||
| N= new indication P= previously cleared in K110673 | |||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | |||||||||
| ** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, | |||||||||
| Contrast Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography. | |||||||||
| Additional Comments: | |||||||||
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | ||||||||
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | ||||||||
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | ||||||||
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | ||||||||
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | ||||||||
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | ||||||||
| Subscript "g": | For Adults and Pediatric patients. |
Prescription Use Only (per 21 CFR 801.109)
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44
System: HI VISION Ascendus
Transducer: EUP-VV531
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined*
(Spec.) | Other** (Spec.) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------|
| General
(Track 1 only) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P |
| | Abdominal | | | | | | | |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging &
Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P |
| | Trans-vaginal | P | P | P | | P | P | P |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Card.) | | | | | | | |
| | Other (Spec.) | | | | | | | |
| Peripheral Vessel | Peripheral Vessel | | | | | | | |
| | Other (Spec.) | | | | | | | |
| | N= new indication P= previously cleared in K110673 | | | | | | | |
| | *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | | | | | | | |
| | **Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging. | | | | | | | |
| | Additional Comments: | | | | | | | |
| | Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | |
| | Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | |
| | Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | |
| | Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | |
| | Subscript "e": Includes imaging for guidance of trans-rectal biopsy. | | | | | | | |
| | Subscript "f": Includes managing for guidance of trans-vaginal biopsy. | | | | | | | |
| | Subscript "g": For Adults and Pediatric patients. | | | | | | | |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
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45
System: HI VISION Ascendus
Transducer: EUP-VV731
Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:
| Clinical Application
General
(Track 1 only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined*
(Spec.) | Other** (Spec.) |
|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---|---|-----|-----|------------------|----------------------|-----------------|
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P |
| Fetal Imaging &
Other | Abdominal | | | | | | | |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P |
| | Trans-vaginal | P | P | P | | P | P | P |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Card.) | | | | | | | |
| | Other (Spec.) | | | | | | | |
| Peripheral Vessel | Peripheral Vessel | | | | | | | |
| | Other (Spec.) | | | | | | | |
| | | | | | | | | |
| N= new indication P= previously cleared in K110673 | | | | | | | | |
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW. | | | | | | | | |
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging. | | | | | | | | |
| Additional Comments: | | | | | | | | |
| Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | | |
| Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | | |
| Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | | |
| Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | | |
| Subscript "e": Includes imaging for guidance of trans-rectal biopsy. | | | | | | | | |
| Subscript "f": Includes managing for guidance of trans-vaginal biopsy. | | | | | | | | |
| Subscript "g": For Adults and Pediatric patients | | | | | | | | |
Prescription Use Only (per 21 CFR 801.109)
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46
510(k) Summary of Safety and Effectiveness in accordance with 21 CFR Part 807, Subpart E, Section 807.92.
21 CFR 807.92, Subsection a
1. Submitter's Information
Hitachi Aloka Medical America, Inc. 10 Fairfield Boulevard Wallingford, CT 06492-5903 On behalf of HITACHI MEDICAL CORPORATION 4-14-1, Soto-Kanda, Chivoda-Ku, Tokyo, JAPAN
Primary Contact Person: Angela Van Arsdale R.A. / O.A. Manager Telephone: (203) 269-5088 Ext: 346 Fax Number: (203) 269-6075
Secondary Contact Person: Lisa DelMonte Regulatory Affairs Product Specialist Telephone: (203) 269-5088 Ext: 348 Fax Number: (203) 269-6075
Date Prepared: November 23, 2015
- Device / Common / Classification Name / Classification / Product Code:
Device Proprietary Name - HI VISION Ascendus Common name - Diagnostic Ultrasound System and Transducers Classification name - System, Imaging, Pulsed Doppler, Ultrasonic Classification: Class II 90-IYN 892.1550 Ultrasonic Pulsed Imaging System Product Code: 90-IYO 892.1560 Ultrasonic Pulsed Echo Imaging System 90-ITX 892.1570 Diagnostic Ultrasound Transducer
4. Device Description:
An ultrasound diagnostic system with the following features:
- Ultrasound transducer(s) = to generate the transmitted ultrasound energy and detect the reflected echoes O
- O Ultrasound transducer accessories (standard and optional) - to maximize functional usage of transducer(s) in various modes of operation
- O A computer system - to control the transducer and analyze the signals resulting from the reflected echoes
- o A video monitor with optional image recorder - to display the computed image or derived Doppler data
47
5. Indication for Use:
HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Trans-esophageal (Cardiac) -Adult/Pediatric, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.
The modes of operation of the HI VISION Ascendus are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Dual Doppler mode, CFI mode (Color Flow Image), Amplitude Dopper (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real-time Virtual Sonography, Realtime Tissue Elastography and Shear Wave Measurement.
6. Comparison to predicate device:
The Hitachi HI VISION Ascendus Ultrasound Electronic Scanner is equivalent to the predicate devices the Hitachi HI VISION Ascendus (K110673). The HI VISION Ascendus has been modified to include features from both the Noblus (K142368) and Siemens S2000/S3000( K130881). The subject and predicate devices are Track III systems.
| Predicate Device | Predicate Device | Predicate Device | Subject Device | |
|---|---|---|---|---|
| HI VISION ASCENDUS | Noblus | Siemens ACUSON | HI VISION ASCENDUS | |
| (K110673) | (K142368) | S2000/S3000 (K130881) | ||
| Intended Use: | Intended for use for Fetal, | |||
| Abdominal, Intr-operative | ||||
| (Spec.), Intra-operative | ||||
| (Neuro.), Laparoscopic, | ||||
| Pediatric, Small Organ | ||||
| (Spec.), Neonatal Cephalic, | ||||
| Adult Cephalic, Trans- | ||||
| rectal, Trans-Vaginal, | ||||
| Musculo-skel. (Convent.), | ||||
| Musculol-skel. (Superfic.), | ||||
| Cardiac Adult, Cardiac | ||||
| Pediatric, Trans-esophageal | ||||
| (card.), Peripheral vessel. | ||||
| The modes of operation are | ||||
| B mode, M mode, PWD | ||||
| (Pulsed Wave Doppler) | ||||
| mode, CWD (Continuous | ||||
| Wave Doppler) mode, | ||||
| Color Doppler, Amplitude | ||||
| Doppler, Harmonic | ||||
| Imaging, Superficial | ||||
| musculoskeletal imaging, | ||||
| and 3D Imaging | Intended for use by trained | |||
| personnel (doctor, | ||||
| sonographer, etx.) for the | ||||
| diagnostic ultrasound | ||||
| evaluation of Abdominal, | ||||
| Cardiac, Intra-operative, | ||||
| Fetal, Pediatric, Small | ||||
| Organ, Peripheral vessel, | ||||
| Biopsy, Trans-rectal, Trans- | ||||
| vaginal, Neonatal Cephalic, | ||||
| Adult Cephalic, Intra- | ||||
| luminal, Gynecology, | ||||
| Urology and Laparoscopic | ||||
| clinical applications. | ||||
| The main features on | ||||
| Noblus are B mode, M | ||||
| mode, PW mode (Pulsed | ||||
| Wave Doppler), CW mode | ||||
| (Continuous Wave | ||||
| Doppler), CFI mode (Color | ||||
| Flow Image), TDI (Tissue | ||||
| Doppler Imaging) and Real- | ||||
| time Tissue Elastography | Iintended for the following | |||
| applications: Fetal, | ||||
| Abdominal, | ||||
| Intraoperative, Pediatric, | ||||
| Small Parts, Transcranial, | ||||
| OB/GYN, Cardiac, Pelvic, | ||||
| Neonatal/Adult Cephalic, | ||||
| Vascular, | ||||
| Musculoskeletal, | ||||
| Superficial | ||||
| Musculoskeletal, and | ||||
| Peripheral Vascular | ||||
| applications. | Intended for use for Fetal, | |||
| Abdominal, Intr-operative | ||||
| (Spec.), Laparoscopic, | ||||
| Pediatric, Small Organ | ||||
| (Spec.), Neonatal Cephalic, | ||||
| Adult Cephalic, Trans- | ||||
| rectal, Trans-Vaginal, | ||||
| Musculo-skel. (Convent.), | ||||
| Musculol-skel. (Superfic.), | ||||
| Cardiac Adult, Cardiac | ||||
| Pediatric, Trans- | ||||
| esophageal (card.), | ||||
| Peripheral vessel. | ||||
| The modes of operation are | ||||
| B mode, M mode, PWD | ||||
| (Pulsed Wave Doppler) | ||||
| mode, CWD (Continuous | ||||
| Wave Doppler) mode, | ||||
| Color Doppler, Amplitude | ||||
| Doppler, Harmonic | ||||
| Imaging, Superficial | ||||
| musculoskeletal imaging, | ||||
| and 3D Imaging. | ||||
| FDA Track: | 3 | 3 | 3 | 3 |
| *Probes: | Convex, Linear, Sector, 4D, | |||
| Other | Convex, Linear, Sector, 4D, | |||
| Other, EUS | Convex, Linear, Sector, | |||
| Other | Convex, Linear, Sector, | |||
| 4D, Other | ||||
| Display Modes: | Combinations of | |||
| B, M, PW, CW | Combinations of | |||
| B, M, PW, CW | Unknown | Combinations of | ||
| B, M, PW, CW | ||||
| Real-time Tissue | ||||
| Elastography | ||||
| (RTTE) with | ||||
| STRAIN | ||||
| RATIO/STRAIN | ||||
| HISTOGRAM* | RTTE only | Real-time Tissue | ||
| Elastography (RTTE) with | ||||
| STRAIN RATIO/STRAIN | ||||
| HISTOGRAM | Applicable | Real-time Tissue | ||
| Elastography (RTTE) with | ||||
| STRAIN RATIO/STRAIN | ||||
| HISTOGRAM | ||||
| SHEAR WAVE | ||||
| ELASTOGRAPHY | ||||
| MEASUREMENT | ||||
| (SWM)* | N/A | N?A | Applicable | SHEAR WAVE |
| ELASTOGRAPHY | ||||
| MEASUREMENT |
48
21 CFR Part 807.92, Section b
-
- Non-clinical Testing
No new hazards were identified with the subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.
- Non-clinical Testing
-
- Clinical testing:
None required
- Clinical testing:
-
- Conclusions:
The HI VISION Ascendus Diagnostic Ultrasound scanner is substantially equivalent in safety and effectiveness to the predicate device(s);
- Conclusions:
-
. The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging and fluid flow analysis.
-
. The subject and predicate device(s) have the same gray scale and Doppler capabilities.
-
The subject and predicate device(s) have the same essential technology for imaging, Doppler functions, and signal processing.
-
. The subject and predicate device(s) have acoustic level below the Track 3 FDA limits.
-
트 The subject and predicate device(s) are manufactured in accordance to FDA 21 CFR 820 Quality System Regulations.
-
. The subject and predicate device(s) are designed and manufactured to the same electrical and physical safety standards.
-
. The subject and predicate device(s) are manufactured with materials that have been tested in accordance to ISO 10993-1; all biocompatibility testing has been conducted in accordance to each component material characterization, type of body contact, and duration contact risk profile.
-
. The subject and predicate device(s) are designed to be re-usable and provide instructions for cleaning. disinfection, and sterilization in the Ultrasound system and transducer manuals.
END OF SUMMARY