(223 days)
The HI VISION Preirus is intended for use by trained personnel (doctor, songrapher, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac. Intra-operative. Fetal. Pediatric. Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.
The Modes of Operation of the HI VISION Preirus are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.
An ultrasound system consists of the following:
- Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the . reflected echoes
- . A computer system to control the transducer and analyze the signals resulting from the reflected echoes
- A video monitor with optional image recorder to display the computed image or derived . Doppler data
The provided document is a 510(k) Premarket Notification for the Hitachi HI VISION Preirus Diagnostic Ultrasound Scanner. It details the device's intended use and claims substantial equivalence to predicate devices, but does not contain a study that proves the device meets specific acceptance criteria for diagnostic performance.
The "Summary of Design Control Activities" section mentions "Verification Activities" and states that "the results demonstrated that the predetermined acceptance criteria were met." However, it only lists general categories of tests performed (Electrical, Mechanical safety; Acoustic output safety; Software; Probe patient contact materials) and refers to external standards (IEC60601-1, FDA Guidance, IEC60601-2-37, ISO10993). It does not provide specific acceptance criteria values or the results of these tests.
Therefore, I cannot populate the table or provide detailed answers to most of your questions as the document does not contain the requested information regarding a diagnostic performance study.
Here's an assessment based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The document states that verification activities were performed and met "predetermined acceptance criteria," but it does not specify what those criteria were in quantitative or qualitative terms for diagnostic performance. It lists general safety and performance characteristics that were verified against standards, but not criteria for clinical efficacy or diagnostic accuracy.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided document. No diagnostic performance study is detailed, therefore no information on test set sample size or data provenance is present.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not available in the provided document. No diagnostic performance study is detailed, therefore no information on ground truth experts or their qualifications is present.
4. Adjudication Method for the Test Set
Not available in the provided document. No diagnostic performance study is detailed, therefore no information on adjudication methods is present.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No. The document does not mention an MRMC comparative effectiveness study involving human readers with or without AI assistance. The device is a diagnostic ultrasound scanner, and its submission focuses on substantial equivalence based on its technological characteristics and intended uses being similar to existing cleared devices, rather than a direct comparison of diagnostic performance with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a diagnostic ultrasound scanner, an imaging system that requires human operation and interpretation. It is not an AI algorithm designed for standalone performance without human input. While it includes "Real Time Tissue Elastography" and "Real Time Virtual Sonography" modes, the document does not describe them as standalone diagnostic algorithms.
7. The Type of Ground Truth Used
Not available in the provided document. No diagnostic performance study is detailed, therefore no information on the type of ground truth used is present. The submission focuses on validating the technical performance and safety of the ultrasound system itself against established standards.
8. The Sample Size for the Training Set
Not applicable/Not available. As there is no mention of a diagnostic performance study for an AI-driven component that would require a "training set" for an algorithm, this information is not relevant or provided. The document describes a medical imaging device, not an AI model that undergoes training on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available. Similar to point 8, this is not relevant to the content provided in the document.
{0}------------------------------------------------
JUN 1 7 2010
Submitter Information
| Submitter: | Hitachi Medical Systems America, Inc.1959 Summit Commerce ParkTwinsburg, Ohio 44087-2371ph: (330) 425-1313fax: (330) 963-0749 | K093466 |
|---|---|---|
| Contact: | Douglas J. Thistlethwaite | |
| Date: | April 26, 2010 |
Device Name
| Classification Name: | System, Imaging, Pulsed Doppler, Ultrasonic | |
|---|---|---|
| Classification Number: | 90-IYN | |
| Trade/Proprietary Name: | HITACHI HI VISION Preirus Diagnostic Ultrasound Scanner | |
| Predicate Device(s): | HI VISION 900 Diagnostic Ultrasound Scanner (K063518)GE Logiq® E9 (K082185)Acuson S2000 (K072786) |
Device Intended Use
The HI VISION Preirus is intended for use by trained personnel (doctor, songrapher, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac. Intra-operative. Fetal. Pediatric. Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.
The Modes of Operation of the HI VISION Preirus are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography..
Device Description
Function
An ultrasound system consists of the following:
- Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the . reflected echoes
- . A computer system to control the transducer and analyze the signals resulting from the reflected echoes
- A video monitor with optional image recorder to display the computed image or derived . Doppler data
Scientific Concepts
An acoustic wave is a mechanical perturbation of a medium which passes through a given medium at a fixed velocity. The rate at which the particles in the medium vibrate in the disturbance is the frequency of the wave, and is measure as cycles/second, or hertz (Hz). Frequencies above 20 kHz are not audible, and above this frequency, the acoustic energy is known as ultrasound. For the purposes of medical ultrasound imaging, frequencies in the range of 1-20 MHz are utilized.
{1}------------------------------------------------
The ultrasound waves comprising a beam travel in as straight line in homogeneous media. When an ultrasound wave reaches an interface between two media of different impedances, a portion of the beam energy may pass through the boundary (transmission), and a portion may be reflected. The direction of propagation of the transmitted beam is determined by the angle of incidence of the incident beam upon the boundary, and differences (if any) in the speed of sound in the two media. The direction of reflection is determined solely by the angle of incidence upon the boundary. The relative strength of the reflected wave depends upon the differences in the impedances between the two media. Reflection at a boundary between soft tissue and bone, as an example, involves a large impedance difference, and results in a relatively strong reflected echo. Reflection at a boundary between two soft tissue-types with a relatively small impedance difference, on the other hand, results in a relatively weak reflected echo.
The ultrasound transducer, when operating in pulsed mode, periodically emits an ultrasound burst at a predetermined rate described as the pulse repetition frequency (PRF). During the time duration that the transducer is not transmitting ultrasound energy, it may act as a received for the reflected ultrasound energy. Since the speed of propagation of ultrasound in tissues is estimated as 1540m/sec, the time elapsed between transmission of a pulse and receipt of an echo may be used to estimate the distance from the transducer to the tissue structure giving rise to the reflected echo. The relative strength of the reflected echo can be used to determine the brightness of display of the reflected echo or strength of derived Doppler signal.
Physical and Performance Characteristics
The principle of operation of ultrasound imaging involves generation of an ultrasound wave with an electric signal applied to a transducer, direction of the resulting ultrasound wave into the tissue of the body, and reception and analysis of the echoes reflected back to the same or an adjacent transducer from the various tissues along the path of the ultrasound wave.
Device Technological Characteristics
The technological characteristics of this device are identical to the primary predicate device. The control and image processing hardware and the base elements of the system software are identical to the predicate device. See Section 4 - Predicate Device Comparison.
Conclusions
It is the opinion of Hitachi Medical Systems America, Inc. that HITACHI HI VISION Preirus Diagnostic Ultrasound Scanner is substantially equivalent to the predicate devices. In addition, we have concluded that the subject system is:
- . Substantially equivalent with respect to safety, effectiveness, and functionality to the HI VISION 900 Diagnostic Ultrasound Scanner (K063518) with the exception of the two new Modes of Operation, Real Time Tissue Elastography and Real Time Virtual Sonography.
- Substantially equivalent with respect to safety and functionality to the GE Logiq® E9 . (K082185) in regards to the device with Real-time Virtual Sonography (RVS)
- Substantially equivalent with respect to safety and functionality to the Acuson S2000 . (K072786) in regards to the device with Real-time Tissue Elastography
Attachment
| ATTACHMENT | POSITION |
|---|---|
| Declaration of Conformity with Design Controls | 1 |
{2}------------------------------------------------
Summary of Design Control Activities
| Items | Tests performed |
|---|---|
| Electrical, Mechanical safety | IEC60601-11See section 1.7.2.1 |
| Acoustic output safety | FDA GuidanceIEC60601-2-372 |
| Software | See section 1.7.5 |
| Probe patient contact materials | ISO109933See section 1.7.3 |
The design validation / verification tests that were performed are listed.
1 Medical Electrical Equipment, Part 1: General Requirements for Safety IEC60601-1
2 Medical Electrical Equipment, Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
3 Biological Evaluation of Medical Device
{3}------------------------------------------------
DECLARATION OF CONFORMITY WITH DESIGN CONTROLS
Verification Activities
To the best of my knowledge, the verification activities, as required by the risk analysis, for the modification were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met.
Name:
H. Noguchi
Title: Manager,
Signature:
H. Noguchi
Ultrasound QA Section, Hitachi Medical Corporation Date: March 31, 2009
Manufacturing Facility
The manufacturing facility, Hitachi Medical Corporation is in conformance with the design control requirements as specified in 21 CFR 820.30 and the records are available for review.
Name:
T. Kasanami
Title: Manager,
Development Design Dept., Ultrasound Systems Division, Hitachi Medical Corporation March 31, 2009 Date:
Signature:
T. Kasami
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JUN 1 7 2010
Mr. Doug Thistlethwaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summitt Commerce Park TWINSBURG OH 44087
Re: K093466 ·
Trade/Device Name: Hitachi HI VISION Preirus Diagnostic Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: June 11, 2010 Received: June 15, 2010
Dear Mr. Thistlethwaite:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the Hitachi HI VISION Preirus Diagnostic Ultrasound Scanner, as described in your premarket notification:
Transducer Model Numbers
EUP-B512 EUP-B514 EUP-C514 EUP-C524 EUP-C532 EUP-C715 EUP-CC531 EUP-CV524 EUP-CV714
| EUP-ES52E |
|---|
| EUP-L52 |
| EUP-L53 |
| EUP-L53L |
| EUP-L65 |
| EUP-L73S |
| EUP-L74M |
| EUP-O54J |
| EUP-R54AW-19--33 |
{5}------------------------------------------------
| EUP-S50A | EUP-V53W |
|---|---|
| EUP-S52 | EUP-VV731 |
| EUP-S70 | Fujinon SP711 |
| EUP-U533 |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely yours.
[signature]
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosures
{6}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: HI VISION Preirus Diagnostic Ultrasound Scanner 1
Indications For Use:
The HI VISION Preirus is intended for use by trained personnel (doctor, songrapher, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.
The Modes of Operation of the Hi VISION Preirus are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (0885) ODV D
Signature
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of
510K. K093466
{7}------------------------------------------------
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | 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 | Pd | Pd | Pd | ||
| Neonatal Cephalic | P | P | P | P | P | P | ||
| Adult Cephalic | P | P | P | P | P | P | P | |
| Trans-rectal | Ph | Ph | Ph | Ph | Ph | Ph | ||
| 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 | P | |||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | ||
| Cardiac Pediatric | P | P | P | P | P | P | P | |
| Trans-esophageal (card.) | Pg | Pg | Pg | P | Pg | Pg | Pg | |
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | P |
| Other (spec.) |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows
indication. P = previously cleared in K063518.
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, 4D Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography
Additional Comments:
System:
| 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. | |
| 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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Bevice Evaluation (OBE) OLUD
SARR
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093466
{8}------------------------------------------------
System: Transducer: EUP-B512
| Intended use. Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows | |
|---|---|
| Clinical Application | Mode of Operation | Combined*(Spec.) | Other**(Spec.) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | |||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | P | ||
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa | ||
| Fetal Imaging& Other | 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.) | |||||||||
| Other (spec.) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (spec.) |
N = new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), Real Time Virtual Songraphy
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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| (PLEASE DO NOT WRITE BELOW THIS LINE) |
WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (OBE) OLL O
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diffision of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093466
.
{9}------------------------------------------------
Transducer: EUP-B514
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows |
|---|
| Clinical Application |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(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 | ||||||||
| 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.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), Real Time Virtual Sonography
.
Additional Comments:
System:
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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| (PLEASE DO NOT WRITE BELOW THIS LINE COMPLETE ON SEPARATE SHEET) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (GBB) Of VD
(Division Sign Off)
(Division Sign-Off)
Division of Radiological Devices
Vitro Diagnostic Devices Excludio Division of Radiological Devices
Office of In Vitro Diagnostic Devices
Lotfice of In Vitro Diagnostic Devices Evaluation and Safety
L
510K. K093446
{10}------------------------------------------------
System: Transducer:
EUP-C514
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | Other**(Spec.) | ||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(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& 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.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Anging, 4D Imaging, 4D 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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
Concurrence of CDRH, Office of Bevice Evaluation (ODE) - O.D. D
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093466
{11}------------------------------------------------
System: Transducer:
EUP-C524
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | 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.) | 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.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD and Color Doppler.
**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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510K: K093466
{12}------------------------------------------------
System: Transducer:
EUP-C532
Intended use. Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | ||
| 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 | ||
| 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.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (spec.) |
N = new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), 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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ・
510K
. ',
(Division Sign-Off)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
{13}------------------------------------------------
System: Transducer: EUP-C715
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | 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 | 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.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), Real Time Virtual Sonography
Additional Comments:
Subscript "2" 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 transrectal biopsy. |
| Subscript "f": Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": For pediatric patients. |
| Subscript "h": Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDBOD Concurrence of CDRH, Office of Device Evaluation (ODE)
ទាលK
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
{14}------------------------------------------------
System: Transducer:
EUP-CC531
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows Chrical Application
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(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& Other | Adult Cephalic | |||||||
| 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), 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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Dovice Evaluation (ODE)
SND
(Division Sign Off) Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K093466
{15}------------------------------------------------
System Transducer:
EUP-CV524
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows | ||
|---|---|---|
| Minion Anningtion------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | The first for any would will be and | No. of children call a comes |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD and Color Doppler.
**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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
510K
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Dovice Eveluzition (ODE)
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Office of In Vitro Diagnostic Device Evaluation and Safety
{16}------------------------------------------------
System: Transducer:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | 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 | Adult Cephalic | |||||||
| & Other | 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 | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N = new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD and Color Doppler.
**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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 180 Concurrence of CDRH, Office of Device Evaluation (QDE)
(Division Sign-Off)
(Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093466
{17}------------------------------------------------
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System Transducer:
HI VISION Preirus EUP-ES52E
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | Combined*(Spec.) | Other**(Spec.) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | |||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| 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.) | P | P | P | P | P | P | P | ||
| Other (spec.) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (spec.) |
N = new indication. P = previously cleared in K063518.
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including ampiocente aig):
| (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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
Premi NE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093966
{18}------------------------------------------------
i
System Transducer: EUP-L52
Intended use . Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows TATHER OFF
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | 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 | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | ||
| Other (spec.) |
N = new indication. P = previously cleared in K063518.
- Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), Real Time Tissue Elastography
Additional Comments:
Subscript "a"
| (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 transrectal biopsy. | |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. | |
| Subscript "g": | For pediatric patients. | |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
SAHB
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093466
{19}------------------------------------------------
System: Transducer:
EUP-L53
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | 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.) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (spec.) |
= new indication. P = previously cleared in K063518. 11
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Aran) & Parts, Bopped.
** 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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients: |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
NE-CONTINUE ON ANOTHER PAGE IF NEEDED DELUY Concurrence of CDRH, Office of Device Evaluation (QDE)
(Division Sign-Olf) Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093466
{20}------------------------------------------------
System: Transducer:
EUP-L53L
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | 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 | 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 | Peripheral vessel | P | P | P | P | P | P | |
| Vessel | Other (spec.) |
N = new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), 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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| (PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) |
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Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093466
{21}------------------------------------------------
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System: Transducer:
HI VISION Preirus EUP-165
| Intended use: Diagnostic ultrasound imaging or fluid.flow analysis if the human body as follows | ||
|---|---|---|
| ------------------------------------- | ||
| A 1 . First All | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Children will consider consisted in consisted in the consistent of the consisted on the |
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | 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 | Peripheral vessel | P | P | P | P | P | P | ||
| Vessel | Other (spec.) |
= new indication. P = previously cleared in K063518.
N = new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), Real Ti
**Amplitude Doppler (Color Flow Angiography), 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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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Division of Radiological Devices
510K K093466
{22}------------------------------------------------
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System: Transducer
HI VISION Preirus
EUP-L73S
| Clinical Application | Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | 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.) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (spec.) | ||||||||
| N = new indication. P = previously cleared in K063518. |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body
N = new indication. P = previously cleared in K063518.
*Combination of each operating mode, B. M., PWD and Color Doppler.
1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
. .
Concurrence of CDRH, Office of Downer Evaluation (013)
(Division Sign-Off) Division of Radiological Devices Office of In Ditision of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093466
{23}------------------------------------------------
System: Transducer:
EUP-L74M
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | 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 | 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | |
| Vessel | Other (spec.) | |||||||
| 11 - 10 - 1 - 1 - 1 - - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - |
new indication. P = previously cleared in K063518. ll
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), 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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
signature
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Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093466
{24}------------------------------------------------
System: Transducer:
EUP-054J
| Intended use. Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows'------------------------------------ | |
|---|---|
| Clinical Annlication | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1A f _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ |
| Clinical Application | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) | |
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | |||||||
| Ophthalmic | ||||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | Pb | Pb | Pb | Pb | Pb | Pb | ||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-Card.)Musculo-skel. (Convent.)Musculo-skel. (Superfic.)Intra-luminalOther (spec.) | P | P | P | P | P | P | ||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | |
| Other (spec.) |
N = new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), Real Time Tissue Elastography
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
| (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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBDED) Concurrence of CDRH, Office of Device Evaluation (0DE)-
510
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Office of In Vitro Diagnostic Devices Evaluation and Safety
{25}------------------------------------------------
System: Transducer
EUP-R54AW-19, -33
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: Clinical Application F
| Clinical Application | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) | |
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | FetalAbdominalIntra-operative (Spec.)Intra-operative (Neuro.)LaparoscopicPediatricSmall Organ (Spec.)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-Card.)Musculo-skel. (Convent.)Musculo-skel. (Superfic.)Intra-luminalOther (spec.) | P | P | P | P | P | P | |
| Cardiac | Cardiac AdultCardiac PediatricTrans-esophageal (card.)Other (spec.) | |||||||
| PeripheralVessel | Peripheral vesselOther (spec.) |
new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), 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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
510K
Concurrence of CDRH, Office of Device Evaluation (ODE)
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{26}------------------------------------------------
System: EUP-S50A Transducer:
Intended use . Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(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 & OtherAdult 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.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | P |
| Other (spec.) |
N = new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), Tissue Doppler 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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093466
{27}------------------------------------------------
System: Transducer:
ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(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& 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 | P | P | P | P | P | P | P | |
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
= new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), Tissue Dopler Inaging
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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED RITE BELOW Concurrence of CDRH, Qffice of Dovice Eveluxtion (ODB)
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Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093464
{28}------------------------------------------------
System: Transducer
EUP-570
Intended use Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(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.) | ||||||||
| Fetal Imaging& Other | 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 Adult | P | P | P | P | P | P | P | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | P |
| Other (spec.) |
new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), Tissue Doppler 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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED SE DO NOT Concurrence of CDRH, Office of Desires Evaluations (00)
Sign Orision Sign-Off)
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Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices Evaluation and Safety
510K K093466
{29}------------------------------------------------
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System: Transducer
HI VISION Preirus EUP-U533
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation | |||||||
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | Ph | Ph | Ph | Ph | Ph | Ph | ||
| 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.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the
indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Dopoler (Color Flow Angiography) Real Color Doppler.
**Amplitude Doppler (Color Flow Angiograph
** Amplitude Doppler (Color Flow Angiography), 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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
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。 ・
{30}------------------------------------------------
System: Transducer
EUP V53W
| intended use. Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows | ||
|---|---|---|
| Commons a ma more comments of the controller | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Comments of the commended to the commend of the comments of the comments of the comments of | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------I |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | P | P | P | P | P | P | |
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||
| 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD and Color Doppler.
** 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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
Concurrence of CDRH, Offices of HODED
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093466
{31}------------------------------------------------
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System: Transducer
HI VISION Preirus EUP-VV731
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(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& 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.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human
N = new indication. P = previously cleared in K063518.
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography)
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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
Concurrence of CDRH, Office of
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093466
{32}------------------------------------------------
System Transducer:
Fujinon SP711
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| 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 | P | |||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication. P = previously cleared in K011252. .
.
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 transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NUMBERED) |
LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Exaluation (000)
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510K K093466
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.