(142 days)
Not Found
No
The 510(k) summary explicitly states that the device and predicate devices have the same essential technology for imaging, Doppler functions, and signal processing, and there is no mention of AI, DNN, or ML in the document.
No
The device is described as an "Ultrasound Diagnostic System" for "diagnostic ultrasound evaluation," indicating its purpose is to diagnose conditions, not to treat them.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "The Hitachi Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation..."
No
The device description explicitly lists hardware components such as ultrasound transducers, a computer system, a battery, and a video monitor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body.
- Device Function: The Hitachi Noblus™ Ultrasound Diagnostic System uses ultrasound waves to create images of internal structures within the body. It is a non-invasive imaging device.
- Intended Use: The intended use clearly describes diagnostic ultrasound evaluation of various anatomical sites in vivo (within the living body).
- Device Description: The description focuses on components related to generating and detecting ultrasound waves and processing the resulting signals to create images. There is no mention of handling or analyzing biological specimens.
Therefore, the Hitachi Noblus™ Ultrasound Diagnostic System is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Hitachi Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative (Spec.), Trans-esophageal (Cardiac, Non-Cardiac) - Adult/Pediatric, Wound (Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biospy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intraluminal, Gynecology, Urology, and Laparoscopic clinical applications.
The modes of operation of the Hitachi Noblus™ Ultrasound Diagnostic System are B mode, M mode, PW mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging and Real Time Tissue Elastography.
Product codes (comma separated list FDA assigned to the subject device)
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
- Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in O various modes of operation
- A computer system to control the transducer and analyze the signals resulting from the reflected echoes o
- A standard Lithium ion computer battery to allow for system portability O
- A video monitor with optional image recorder to display the computed image or derived Doppler data O
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Cardiac, Intra-operative (Spec.), Trans-esophageal (Cardiac, Non-Cardiac), Wound (Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intraluminal, Gynecology, Urology, Laparoscopic
Indicated Patient Age Range
Adult/Pediatric, Neonatal, Fetal
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)
The Noblus™ free-hand scanning method used for 3D visualization is the same as the Hitachi HI VISION ASCENDUS Diagnostic Ultrasound Scanner cleared via K110673.
The Noblus™ Real Time Tissue Elastography feature incorporates a strain ratio feature, which is substantially equivalent to the Siemen Acuson S2000 [K130881] Supersonic Image Shearwave Elastography feature. Both Strain Ratio and Supersonic Image Shearwave provides color graph of tissue strain (hardness of tissue) to assist in visualization and perimeter of a tumor, lump or mass in liver, breast, thyroid, etc. for biopsy purposes. The addition of strain ratio to the Noblus™ Real Time Tissue Elastography feature does not additional risk. The Elastography Strain Ratio feature provides Physicians additional empirical data that may be used in conjunction with other medical data to assist in clinical diagnosis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K130308, K110673, K130881, K022928
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2015
Hitachi Aloka Medical, Ltd. % Ms. Angela Van Arsdale Regulatory Affairs /Ouality Assurance Manager 10 Fairfield Blvd. WALLINGFORD CT 06492
Re: K142368
Trade/Device Name: Noblus™ Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: December 29, 2014 Received: December 30, 2014
Dear Ms. Van Arsdale:
EG-3270UK
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.
This determination of substantial equivalence applies to the following transducers intended for use with the Noblus" Ultrasound Diagnostic System, as described in your premarket notification:
| Transducer Model Number | ||||
|---|---|---|---|---|
| C22K | C22P | C25 | C251 | C35 |
| C41 | C41B | C41L47RP | C41V | C41V1 |
| C42 | C42K | CC41R | EUP-B512 | EUP-B715 |
| EUP-C715 | EUP-CC531S | EUP-L53L | EUP-L74M | EUP-O53T |
| EUP-O54J | EUP-O732T | EUP-OL334 | L34 | L44 |
| L441 | L55 | L64 | R41R | S21 |
| S211 | S31 | VC34A | UST-2265-2 | EB-1970UK |
EG-3870UTK
S3ESS / S3ESL
EG-3670URK
1
EUP-R54AW-19 / EUP-R54AW-33
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 mav 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance 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 vours.
Robert A Ochs
Robert Ochs, Ph.D. Acting 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) K142368
Device Name Noblus TM Ultrasound Diagnostic System
Indications for Use (Describe)
The Hitachi Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative (Spec.), Trans-esophageal (Cardiac, Non-Cardiac) - Adult/Pediatric, Wound (Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biospy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intraluminal, Gynecology, Urology, and Laparoscopic clinical applications.
The modes of operation of the Hitachi Noblus™ Ultrasound Diagnostic System are B mode, M mode, PW mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging and Real Time Tissue Elastography.
Type of Use (Select one or both, as applicable)
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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3
System: Noblus
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 | Color | |||
| Doppler | 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.) | 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 | 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.) | Ng | Ng | Ng | Ng | Ng | Ng | Ng | |
| Musculo-skel. (Convent.) | P | P | P | P | P | P | ||
| Musculo-skel. (Superfic.) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (spec.) - Wound | Nh | Nh | Nh | Nh | Nh | Nh | ||
| Other (spec.) - Gynecologic | P | P | P | P | P | P | ||
| Endoscopy | P | P | P | P | P | P | ||
| Cardiac Adult | P | P | P | P | P | P | P | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| Trans-esophageal (card.) | Ng | Ng | Ng | Ng | Ng | Ng | Ng | |
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | P |
| Other (spec.) | ||||||||
| N = new indication. P = previously cleared in K130308 | ||||||||
| *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 | ||||||||
| 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. For Adult and Pediatric patients.
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy. Subscript "g":
Subscript "h": Includes imaging for Cavernous/Non-Cavernous wounds.
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 2 of 42
4
Noblus System:
C22K 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 | Color | ||||
| Doppler | 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 | |||||||||
| 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.) - Wound | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) | |||||||||
| N = new indication. P = previously cleared in K130308 | |||||||||
| *Combination of each operating mode, B, M, PWD and Color Doppler. | |||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D 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 imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and Pediatric patients. Subscript "h": Includes imaging for Cavernous/Non-Cavernous wounds.
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 3 of 42
5
| System: | Noblus |
|---|---|
| Transducer: | C22P |
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 | Color Doppler | Combined* | ||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | P | P | P | P | P | P | ||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | Pa | Pa | Pa | Pa | Pa | Pa | ||
| 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.) - Wound | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication. P = previously cleared in K134016 & K140443
*Combination of each operating mode, B, M, PWD, and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), 3D 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 imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For Adult and Pediatric patients. |
| Subscript "h": | Includes imaging for Cavernous/Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 4 of 42
6
System: Noblus
C25 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 | 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 | 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.) - Wound | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication. P = previously cleared in K130308
*Combination of each operating mode, B, M, PWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), 3D Imaging
Additional Comments:
| 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 imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For Adult and Pediatric patients. |
| Subscript "h": | Includes imaging for Cavernous/Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 5 of 42
7
Noblus System:
C251 Transducer:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Specific
PWD
CWD
Combined*
Other**
General
B
M
Color
(Track I only)
Doppler
(Tracks I & III)
(Spec.)
(Spec.)
Ophthalmic
Ophthalmic
Fetal
P
P
P
P
P
P
Abdominal
Pa
Pa
Pa
Pa
Pa
Pa
Intra-operative (Spec.)
Intra-operative (Neuro.)
Laparoscopic
P
P
P
P
P
P
Pediatric
Small Organ (Spec.)
Pd
Pd
Pd
Pd
Pd
Pd
Neonatal Cephalic
Adult Cephalic
Fetal Imaging
& Other
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.) - Wound
Cardiac Adult
Cardiac Pediatric
Cardiac
Trans-esophageal (card.)
Other (spec.)
Peripheral
Peripheral vessel
Vessel
Other (spec.)
N = new indication. P = previously cleared in K134016 & K140443
| *Combination of each operating mode, B, M, PWD and Color Doppler. | Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ** Amplitude Doppler (Color Flow Angiography), 3D Imaging | ||||||||||
| 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. | ||||||||||
| Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | ||||||||||
| Subscript "d": | ||||||||||
| Subcorint "all. | ||||||||||
| Includes imaging for midance of trans ractal hioney. |
Includes imaging for guidance of trans-rectal biopsy. Subscript "e"
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy. For Adult and Pediatric patients.
Subscript "g": Subscript "h": Includes imaging for Cavernous/Non-Cavernous wounds.
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 6 of 42
8
System: Noblus
Transducer: C35
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 | 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 | 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.) - Wound | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | ||||||||
| N = new indication. P = previously cleared in K134016 | ||||||||
| *Combination of each operating mode, B, M, PWD and Color Doppler. | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D 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 imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For Adult and Pediatric patients. |
| Subscript "h": | Includes imaging for Cavernous/Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 7 of 42
9
System: Noblus
Transducer: C41
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 | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (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 | ||
| Small Organ (Spec.) | Pc | Pc | Pc | Рс | Рс | Рс | ||
| 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.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) - Wound | ||||||||
| 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 K130308 & K134016 |
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), 3D 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 imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for Cavernous/Non-Cavernous wounds |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 8 of 42
10
System: Noblus
C41B 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 | Color | ||||
| Doppler | Combined* | ||||||||
| (Spec.) | Other** | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | |||
| Abdominal | |||||||||
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Spec.) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Other | Adult Cephalic | ||||||||
| Trans-rectal | Ne | Ne | Ne | Ne | Ne | Ne | Ne | ||
| Trans-vaginal | Nf | Nf | Nf | Nf | Nf | Nf | Nf | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) - Wound | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) | |||||||||
| N = new see Appendix 1. P = previously cleared in K130308 | |||||||||
| *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 trans-rectal biopsy. |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For Adult and Pediatric patients. |
| Subscript "h": | Includes imaging for Cavernous/Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 9 of 42
11
System: Noblus
Transducer: C41L47RP
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 | Color | |||
| Doppler | 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 | Pe | Pe | Pe | Pe | Pe | Pe | ||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) - Wound | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | ||||||||
| N = new indication. P = previously cleared in K134016 & K140443 |
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 4D 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 imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For Adult and Pediatric patients. |
| Subscript "h": | Includes imaging for Cavernous/Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 10 of 42
12
System: Noblus
Transducer: C41V
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 | Color | |||
| Doppler | 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.) - Gynecological | P | P | P | P | P | P | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | ||||||||
| N = new indication. P = previously cleared in K130308 | ||||||||
| *Combination of each operating mode, B, M, PWD and Color Doppler. | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Real Time Tissue Elastography | ||||||||
| Additional Comments: | ||||||||
| Includes imaging for guidance of percutaneous biopsies of abdominal organs and structures (including amniocentesis) |
| 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 imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For Adult and Pediatric patients. |
| Subscript "h": | Includes imaging for Cavernous/Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 11 of 42
13
System: Noblus
Transducer: C41V1
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 | Color | |||
| Doppler | 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.) - Gynecological | P | P | P | P | P | P | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | ||||||||
| N = new indication. P = previously cleared in K134016 & K140443 | ||||||||
| *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 trans-rectal biopsy. | ||||||||
| Subscript "f": Includes imaging for guidance of trans-vaginal biopsy. |
Subscript "h": Includes imaging for Cavernous/Non-Cavernous wounds.
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 12 of 42
14
System: Noblus
C42 Transducer:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | Combined* | Other** |
| (Track I only) | (Tracks I & III) | Doppler | (Spec.) | (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 | b | ||
| 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.) - Wound | ||||||||
| 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 K130308 | ||||||||
| *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 trans-rectal biopsy. | |||||||
| Subscript "f": | ||||||||
| Includes imaging for guidance of trans-vaginal biopsy. |
Prescription Use Only (per 21 CFR 801.109)
For Adult and Pediatric patients.
Includes imaging for Cavernous/Non-Cavernous wounds.
Subscript "g":
Subscript "h":
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign – Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:_
Page 13 of 42
15
System: Noblus
C42K 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 | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | Pb | Pb | Pb | Pb | Pb | Pb | ||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| 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.) - Wound | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | ||||||||
| N = new indication. P = previously cleared in K130308 & K134016 | ||||||||
| *Combination of each operating mode, B, M, PWD and Color Doppler. | ||||||||
| ** Amplitude Doppler (Color Flow Angiography), 3D 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 laparosopic 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 imaging for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adult and Pediatric patients. | |||||||
| Subscript "h": | Includes imaging for Cavernous/Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 14 of 42
16
System: Noblus
Transducer: CC41R
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 | Color | ||||
| Doppler | 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.) - Wound | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) | |||||||||
| N = new indication. P = previously cleared in K134016 & K140443 | |||||||||
| *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 trans-rectal biopsy.
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and Pediatric patients.
Subscript "h": Includes imaging for Cavernous/Non-Cavernous wounds.
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 15 of 42
17
System: Noblus
Transducer: EUP-B512
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 | 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.) - Wound | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | ||||||||
| N = new indication. P = previously cleared in K093466, K102901 & K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD, and Color Doppler. | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D 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 imaging for guidance of trans-vaginal biopsy. |
Prescription Use Only (per 21 CFR 801.109)
For Adult and Pediatric patients.
Includes imaging for Cavernous/Non-Cavernous wounds.
Subscript "g":
Subscript "h":
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(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 16 of 42
18
System: Noblus
EUP-B715 Transducer:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | ||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| (Track I only) | (Tracks I & III) | |||||||
| 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.) - Wound | ||||||||
| 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. | ||||||||
| ** Amplitude Doppler (Color Flow Angiography), 3D 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 imaging for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adult and Pediatric patients. | |||||||
| Subscript "h": | Includes imaging for Cavernous/Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:_
Page 17 of 42
19
System: Noblus
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 | 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 | 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.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) - Wound | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | ||||||||
| N = new indication. P = previously cleared in K093466, K102901 & K110673 | ||||||||
| *Combination of each operating mode, B, M, PWD and Color Doppler. | ||||||||
| **Amplitude Doppler (Color Flow Angiography), 3D 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 imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and Pediatric patients.
Subscript "h": Includes imaging for Cavernous/Non-Cavernous wounds.
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 18 of 42
20
System: Noblus
EUP-CC531S Transducer:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Combined* | |||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | ||||||||
| 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 | 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.) - Wound | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
Additional Comments:
| 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 imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For Adult and Pediatric patients. |
| Subscript "h": | Includes imaging for Cavernous/Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 19 of 42
21
System: Noblus
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 | 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.) - Wound | |||||||||
| 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 K093466, K102901 & K110673 | |||||||||
| *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 trans-rectal biopsy.
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and Pediatric patients.
Includes imaging for Cavernous/Non-Cavernous wounds. Subscript "h":
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 20 of 42
22
System: Noblus
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 | 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.) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (spec.) - Wound | ||||||||
| 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 K093466, K102901 & K110673 | ||||||||
| *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. |
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 imaging for guidance of trans-vaginal biopsy.
Subscript "f": Subscript "g": For Adult and Pediatric patients.
Subscript "h": Includes imaging for Cavernous/Non-Cavernous wounds.
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 21 of 42
23
System: Noblus
Transducer: EUP-053T
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 | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | Pb | Pb | Pb | Pb | Pb | Pb | ||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) - Wound | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
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 imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and Pediatric patients. Subscript "h": Includes imaging for Cavernous / Non-Cavernous wounds.
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:_
Page 22 of 42
24
| System: | Noblus | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | EUP-054J | |||||||
| 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 | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other* | |||||||
| (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 | ||||||||
| & 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.) - Wound | ||||||||
| 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 K130308 | ||||||||
| *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 trans-rectal biopsy. | |||||||
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adult and Pediatric patients. | |||||||
| Subscript "h": | Includes imaging for Cavernous / Non-Cavernous wounds. | |||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (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 | ||||||||
| & Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) - Wound | ||||||||
| 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. | ||||||||
| **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). |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:_ and the same of the same of the same of the same of the same of the same of
Page 23 of 42
25
System: Noblus
Transducer: EUP-0732T
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
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 imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and Pediatric patients. Subscript "h": Includes imaging for Cavernous / Non-Cavernous wounds.
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 24 of 42
26
System: Noblus
EUP-OL334 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 | 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.) - Wound | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) | |||||||
| N = new indication. P = previously cleared in K130308 | ||||||||
| *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 trans-rectal biopsy. |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For Adult and Pediatric patients. |
| Subscript "h": | Includes imaging for Cavernous / Non-Cavernous wounds |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 25 of 42
27
System:
EUP-R54AW-19 / EUP-R54AW-33 Transducer:
Noblus
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 | Color | |||
| Doppler | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| 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 | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) - Wound | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
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 imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For Adult and Pediatric patients. |
| Subscript "h": | Includes imaging for Cavernous / Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign – Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 26 of 42
28
System: Noblus
Transducer: L34
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 | 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.) - Wound | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P | ||
| Other (spec.) |
** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Real Time Tissue Elastography
Additional Comments:
| Additional Conditions: | |
|---|---|
| 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 imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For Adult and Pediatric patients. |
| Subscript "h": | Includes imaging for Cavernous / Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 27 of 42
29
System: Noblus
Transducer: L44
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 | 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.) | P | P | P | P | P | P | |||
| Intra-luminal | |||||||||
| Other (spec.) - Wound | |||||||||
| 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 K130308 |
*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 trans-rectal biopsy. |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For Adult and Pediatric patients. |
| Subscript "h": | Includes imaging for Cavernous / Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 28 of 42
30
System: Noblus
Transducer: L441
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 | 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 | bd | Pd | Pd | |||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | Adult Cephalic | ||||||||
| & Other | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | P | P | b | P | P | P | |||
| Musculo-skel. (Superfic.) | P | P | P | P | P | P | |||
| Intra-luminal | |||||||||
| Other (spec.) - Wound | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | Peripheral vessel | P | P | b | P | P | P | ||
| Vessel | Other (spec.) | ||||||||
| N = new indication. P = previously cleared in K134016 & K140443 |
*Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), Tissue Doppler 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 imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For Adult and Pediatric patients. |
| Subscript "h": | Includes imaging for Cavernous / Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 29 of 42
31
| System: | Noblus | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | L55 | |||||||
| 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 | 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.) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (spec.) - Wound | Nh | Nh | Nh | Nh | Nh | Nh | ||
| 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 K130308 | ||||||||
| *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 trans-rectal biopsy. | |||||||
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adult and Pediatric patients. |
(Division Sign – Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
510(k) Number:_
Page 30 of 42
32
System: Noblus
Transducer: L64
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 | 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.) | P | P | P | P | P | P | ||
| Intra-luminal | ||||||||
| Other (spec.) - Wound | Nh | Nh | Nh | Nh | Nh | Nh | ||
| 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 K130308 |
*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 trans-rectal biopsy. |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For Adult and Pediatric patients. |
| Subscript "h": | Includes imaging for Cavernous / Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 31 of 42
33
System: Noblus
Transducer: R41R
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | Combined* | |
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| (Track I only) | (Tracks I & III) | Doppler | ||||||
| Ophthalmic | Ophthalmic | |||||||
| 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 | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) - Wound | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
| 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 imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and Pediatric patients. Subscript "h": Includes imaging for Cavernous / Non-Cavernous wounds.
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 32 of 42
34
| System: | Noblus | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | S21 | |||||||
| 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 | Color | |||
| Doppler | 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.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | ||||||||
| & Other | 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.) - Wound | ||||||||
| 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 K130308
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
**Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D 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 imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and Pediatric patients.
Subscript "h": Includes imaging for Cavernous / Non-Cavernous wounds.
Prescription Use Only (per 21 CFR 801.109)
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:__ and the same of the same of the same of the same of the same of the same of
Page 33 of 42
35
System: Noblus
Transducer: S211
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 | Color | |||
| Doppler | 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.) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal Imaging | ||||||||
| & Other | 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.) - Wound | ||||||||
| 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.) |
Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D 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 imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For Adult and Pediatric patients. |
| Subscript "h": | Includes imaging for Cavernous / Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
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(Division Sign – Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 34 of 42
36
System: Noblus
Transducer: S31
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 | Color | ||||
| Doppler | Combined* | ||||||||
| (Spec.) | Other** | ||||||||
| (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 | |||||||||
| & Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) - Wound | |||||||||
| 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 | ||||||||
| Other (spec.) |
Additional Comments:
| 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 imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": For Adult and Pediatric patients. |
| Subscript "h": Includes imaging for Cavernous / Non-Cavernous wounds |
Prescription Use Only (per 21 CFR 801.109)
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(Division Sign – Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 35 of 42
37
System: Noblus
S3ESS / S3ESL 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 | Color | |||
| Doppler | 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.) | Ng | Ng | Ng | Ng | Ng | Ng | Ng | |
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) - Wound | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | Ng | Ng | Ng | Ng | Ng | Ng | Ng | |
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | ||||||||
| N = new indication. P = previously cleared | ||||||||
| *Combination of each operating mode, B, M, PWD, CWD and Color Doppler. | ||||||||
| **Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D 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 imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and Pediatric patients.
Subscript "h": Includes imaging for Cavernous / Non-Cavernous wounds.
Prescription Use Only (per 21 CFR 801.109)
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(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 36 of 42
38
System: Noblus
VC34A 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 | 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 | 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.) - Wound | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | ||||||||
| N = new indication. P = previously cleared in K130308 |
Combination of each operating mode, B, M, PWD and Color Doppler.
** Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging
Additional Comments:
| Additional Conditions: | |
|---|---|
| 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 imaging for guidance of trans-vaginal biopsy. |
| Subscript "g": | For Adult and Pediatric patients. |
| Subscript "h": | Includes imaging for Cavernous / Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
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(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 37 of 42
39
System: Noblus
UST-2265-2 Transducer:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | ||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| (Track I only) | (Tracks I & III) | |||||||
| 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.) - Wound | ||||||||
| Cardiac Adult | P | |||||||
| Cardiac | Cardiac Pediatric | P | ||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | ||||||
| Other (spec.) | ||||||||
| N = new indication. P = previously cleared in K033311, K032875, K040719, K122537, K134016, K140443 & K140639 | ||||||||
| 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 imaging for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adult and Pediatric patients. | |||||||
| Subscript "h": | Includes imaging for Cavernous / Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
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(Division Sign - Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 38 of 42
40
System: Noblus
EB-1970UK 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 | Color | |||
| Doppler | 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 | ||||||||
| Other (spec.) - Wound | ||||||||
| Endoscopy | P | P | P | P | P | P | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | ||||||||
| N = new indication. P = previously cleared in K131946 & K130308 | ||||||||
| 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 laparosopic 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 imaging for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adult and Pediatric patients. | |||||||
| Subscript "h": | Includes imaging for Cavernous / Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
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(Division Sign – Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 39 of 42
41
System: Noblus
EG-3270UK 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 | Color | |||
| Doppler | 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 | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) - Wound | ||||||||
| Endoscopy | P | P | P | P | P | P | ||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | ||||||||
| N = new indication. P = previously cleared in K130247 & K130308 | ||||||||
| 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 imaging for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adult and Pediatric patients. | |||||||
| Subscript "h": | Includes imaging for Cavernous / Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
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(Division Sign – Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 40 of 42
42
System: Noblus
EG-3670URK Transducer:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | ||
| Doppler | Combined* | |||||||
| (Spec.) | Other** | |||||||
| (Spec.) | ||||||||
| (Track I only) | (Tracks I & III) | |||||||
| 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.) - Wound | ||||||||
| Endoscopy | P | P | P | P | P | P | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | ||||||||
| N = new indication. P = previously cleared in K130206 & K130308 | ||||||||
| 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 imaging for guidance of trans-vaginal biopsy. | |||||||
| Subscript "g": | For Adult and Pediatric patients. | |||||||
| Subscript "h": | Includes imaging for Cavernous / Non-Cavernous wounds. |
Prescription Use Only (per 21 CFR 801.109)
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(Division Sign – Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 41 of 42
43
System: Noblus
EG-3870UTK Transducer:
Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | Combined* | Other** | |
| (Track I only) | (Tracks I & III) | Doppler | (Spec.) | (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.) - Wound | |||||||||
| Endoscopy | P | P | P | P | P | P | |||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (spec.) | ||||||||
| N = new indication. P = previously cleared in K130247 & K130308 | |||||||||
| 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 imaging for Cavernous / Non-Cavernous wounds. | ||||||||
| Subscript "g": | For Adult and Pediatric patients. | ||||||||
| Subscript "h": | Includes imaging for guidance of trans-vaginal biopsy. |
Prescription Use Only (per 21 CFR 801.109)
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(Division Sign – Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number:
Page 42 of 42
44
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
- Submitter's Information
Hitachi Aloka Medical America, Inc 10 Fairfield Boulevard Wallingford, CT 06492-5903
Primary Contact Person: Angela Van Arsdale R.A. / O.A. Manager Telephone: (203) 269-5088 Ext: 346 Fax Number: (203) 269-6075
Manufacturer: Hitachi Medical Corporation 4-14-1, Soto-Kanda, Chiyoda-Ku, Tokyo, Japan
Date Prepared: August 7, 2014
- Device / Common / Classification Name / Classification / Product Code:
Device Proprietary Name - Noblus™ Diagnostic Ultrasound System Common name - Diagnostic Ultrasound System and Transducers Classification name - System, Imaging, Pulsed Doppler, Ultrasonic Classification: Class II Product Code: 90-IYN 892.1550 Ultrasonic Pulsed Imaging System 90-IYO 892.1560 Ultrasonic Pulsed Echo Imaging System 90-ITX 892.1570 Diagnostic Ultrasound Transducer
3. Legally Marketed Predicate Device(s):
Hitachi Noblus™ Diagnostic Ultrasound System [K130308] HI VISION ASCENDUS Diagnostic Ultrasound Scanner [K110673] Siemens Medical Solutions USA, Inc. [K130881] Hudson 2060 Ultrasound Scanner [K022928]
- 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
- Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in O various modes of operation
- A computer system to control the transducer and analyze the signals resulting from the reflected echoes o
- A standard Lithium ion computer battery to allow for system portability O
- A video monitor with optional image recorder to display the computed image or derived Doppler data O
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5. Indication for Use:
The Hitachi Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative (Spec.), Trans-esophageal (Cardiac/Non-Cardiac) - Adult/Pediatric, Wound (Cavernous/Non-Cavernous),, 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 Hitachi Noblus™ Ultrasound Diagnostic System are B mode, M mode, PW mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, and Real Time Tissue Elastography.
6. Comparison to predicate device:
The subject device Hitachi Noblus™ Diagnostic Ultrasound device is technically comparable and substantially equivalent to the predicate Hitachi Noblus™ Diagnostic Ultrasound device [K130308]. Both are track 3systems that incorporate the same fundamental and scientific technologies. The subject system has expanded indications intended use and additional transducers than the predicate system.
The Noblus™ is capable of scanning wounds in the same manner as the predicate Hudson 2020/2040/2060 scanner [K022928]. Wound scanning with the Noblus™ system does not add any additional risk while providing the same supportive evidence in medical diagnosis of disease state as the currently cleared predicate device [K022928].
The Noblus™ free-hand scanning method used for 3D visualization is the same as the Hitachi HI VISION ASCENDUS Diagnostic Ultrasound Scanner cleared via K110673.
The Noblus™ Real Time Tissue Elastography feature incorporates a strain ratio feature, which is substantially equivalent to the Siemen Acuson S2000 [K130881] Supersonic Image Shearwave Elastography feature. Both Strain Ratio and Supersonic Image Shearwave provides color graph of tissue strain (hardness of tissue) to assist in visualization and perimeter of a tumor, lump or mass in liver, breast, thyroid, etc. for biopsy purposes. The addition of strain ratio to the Noblus™ Real Time Tissue Elastography feature does not additional risk. The Elastography Strain Ratio feature provides Physicians additional empirical data that may be used in conjunction with other medical data to assist in clinical diagnosis.
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21 CFR Part 807.92, Section b
1. Non-clinical Testing
No new hazards were identified with the subject device. 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.
2. Clinical testing:
None required
3. Conclusions:
The Hitachi Aloka Medical, Ltd. Noblus™ Diagnostic Ultrasound scanner is substantially equivalent in safety and effectiveness to the predicate devices;
- I The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging and fluid flow analysis.
- I 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.
- I 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.
- . The subject and the predicate K022928 are both safe and effective for wound scanning.
- I The subject and the predicate K110673 are both safe and effective for a free-hand scanning method used for 3D visualization
- . The subject device is safe and effective with the use of a fully featured Real Time Tissue Elastography (RTTE) inclusive of Strain Ratio. Strain Ratio component of the Noblus™ RTTE is equivalent to the Supersonic Image Shearwave Elastography predicate K130881.