NOBLUS™ Ultrasound Diagnostic System

K160559 · Hitachi Medical Corporation · IYN · Oct 18, 2016 · Radiology

Device Facts

• Record ID: K160559
• Device Name: NOBLUS™ Ultrasound Diagnostic System
• Applicant: Hitachi Medical Corporation
• Product Code: IYN · Radiology
• Decision Date: Oct 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The 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.), Intra-operative (Neuro.), Transesophageal (Cardiac) - Adult/Pediatric, Wound (Cavernous/Non-Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology, and Laparoscopic clinical applications.

Device Story

The Noblus™ Ultrasound Diagnostic System is a diagnostic ultrasound imaging device used by trained clinicians (doctors, sonographers) in clinical settings. It utilizes ultrasound transducers to transmit energy into the body and detect reflected echoes. A computer system processes these signals to generate images and Doppler data, which are displayed on a monitor. The system supports various modes, including B-mode, M-mode, Pulse Wave/Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging (TDI), 3D/4D imaging, and Real Time Tissue Elastography. Clinicians use the visual output to perform diagnostic evaluations and guide procedures like biopsies. The device aids in clinical decision-making by providing real-time anatomical and physiological information, potentially improving diagnostic accuracy and patient outcomes.

Clinical Evidence

No clinical data was required. Substantial equivalence was established through bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, electromagnetic compatibility, and electrical/mechanical safety, all conforming to applicable standards.

Technological Characteristics

The system uses ultrasound transducers for imaging and Doppler analysis. It features a computer-based signal processing unit and a video monitor. Materials comply with ISO 10993-1 biocompatibility standards. The system is a Track III device with 64 transmit channels. It supports various display modes including B, M, PW, CW, and Color Doppler. Sterilization/disinfection is performed per provided instructions.

Indications for Use

Indicated for diagnostic ultrasound evaluation of abdominal, cardiac, intra-operative, transesophageal, wound, fetal, pediatric, small organ, peripheral vessel, biopsy, trans-rectal, musculoskeletal, neonatal cephalic, endoscopic, intra-luminal, gynecological, urological, and laparoscopic applications in adult and pediatric patients.

Regulatory Classification

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.

Predicate Devices

• Noblus™ Ultrasound Diagnostic System (K142368)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they appear to be layered or overlapping. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

December 6, 2016

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Hitachi Medical Corporation % Ms. Angela Van Arsdale RA/QA Manager Hitachi Aloka Medical America, Inc. 10 Fairfield Blvd. WALLINGFORD CT 06492

Re: K160559

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: October 13, 2016 Received: October 14, 2016

Dear Ms. Van Arsdale:

This letter corrects our substantially equivalent letter of October 18, 2016.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours

Jeff Rothen

For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

Device Name

NOBLUSTM Ultrasound Diagnostic System

### Indications for Use (Describe)

The 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.), Intra-operative (Neuro.), Transesophageal (Cardiac) - Adult/Pediatric, Wound (Cavernous/Non-Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, 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 (Pulse Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D 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)

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| Transducer: | All connectable probes | | | | | | | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|----|-----|-----|------------------|----------------------|--------------------|
| | 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<br>Doppler | Combined*<br>(Spec.) | Other**<br>(Spec.) |
| (Track I only) | (Tracks I & III) | | | | | | | |
| 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.) | N | N | N | | N | N | N |
| | 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 | Adult Cephalic | P | P | P | P | P | P | P |
| & Other | Trans-rectal | Pe | Pe | Pe | | Pe | Pe | Pe |
| | Trans-vaginal | Pf | Pf | Pf | | Pf | Pf | Pf |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | Pg | Pg | Pg | | Pg | Pg | Pg |
| | Musculo-skel. (Convent.) | P | P | P | | P | P | P |
| | Musculo-skel. (Superfic.) | P | P | P | | P | P | P |
| | Intra-luminal | | | | | | | |
| | Other (spec.) - Wound | Ph | Ph | Ph | | Ph | Ph | Ph |
| | Other (spec.) - Gynecological | P | P | P | | P | P | P |
| | Other (spec.) - Endoscopy | P | P | P | | P | P | P |
| | Other (spec.) - | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| | Trans-esophageal (card.) | Pg | Pg | Pg | Pg | Pg | Pg | Pg |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | P | P | P | P |
| Vessel | Other (spec.) - | | | | | | | |
| | N = new indication. P = previously cleared in K142368<br>*Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW,<br>TDI-B/B. TDI-B/M, TDI-B/PW<br>** Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, 4D Imaging, Omni Directional M mode, Wide View,<br>Contrast Imaging, Real Time Tissue Elastography | | | | | | | |
| Additional Comments: | | | | | | | | |
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | |
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | | | | | | | |
| Subscript "f": | Includes 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)

Noblus

System:

(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:_

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| DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM | | | | | | | | |
|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----|----|-----|-----|------------------|----------------------|--------------------|
| System: | Noblus | | | | | | | |
| Transducer: | C221 | | | | | | | |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | |
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spec.) | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | P | P | P | | P | P | P |
| | Intra-operative (Spec.) | Pb | Pb | Pb | | Pb | Pb | Pb |
| | 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 | | | | | | | |
| | Other (spec.) - Gynecological | | | | | | | |
| | Other (spec.) - Endoscopy | | | | | | | |
| | Other (spec.) - | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) - | | | | | | | |
| | N = new indication. P = previously cleared in K142368 | | | | | | | |
| | * Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,<br>CFM-B/PW | | | | | | | |
| | ** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging | | | | | | | |
| Additional Comments: | | | | | | | | |
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | |
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | | | | | | | |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. | | | | | | | |
| Subscript "g": | For Adult and Pediatric patients. | | | | | | | |
| Subscript "h": | Includes imaging for Cavernous/Non-Cavernous wounds | | | | | | | |

### (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:_

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| System: | Noblus | | | | | | | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------|----|-----|-----|------------------|----------------------|--------------------|
| Transducer: | C22K | | | | | | | |
| Intended use: | Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spec.) | Other**<br>(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<br>& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) - Wound | | | | | | | |
| | Other (spec.) - Gynecological | | | | | | | |
| | Other (spec.) - Endoscopy | | | | | | | |
| | Other (spec.) - | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) - | | | | | | | |
| | N = new indication. P = previously cleared in K142368 | | | | | | | |
| | * Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, | | | | | | | |
| | CFM-B/PW | | | | | | | |
| | ** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging | | | | | | | |
| Additional Comments: | | | | | | | | |
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | |
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | | | | | | | |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. | | | | | | | |
| Subscript "g": | For Adult and Pediatric patients. | | | | | | | |
| Subscript "h": | Includes imaging for Cavernous/Non-Cavernous wounds | | | | | | | |

(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:________________________________________________________________________________________________________________________________________________________________

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| System: | Noblus | | | | | | | | |
|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------|----|----|-----|-----|------------------|----------------------|--------------------|
| Transducer: | C22P | | | | | | | | |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: | | | | | | | | | |
| Clinical Application | General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spec.) | Other**<br>(Spec.) |
| Ophthalmic | Ophthalmic | Fetal | P | P | P | | P | P | P |
| | | Abdominal | Pa | Pa | Pa | | Pa | Pa | Pa |
| Fetal Imaging<br>& Other | | Intra-operative (Spec.) | | | | | | | |
| | | Intra-operative (Neuro.) | | | | | | | |
| | | Laparoscopic | | | | | | | |
| | | Pediatric | | | | | | | |
| | | Small Organ (Spec.) | | | | | | | |
| | | Neonatal Cephalic | | | | | | | |
| | | Adult Cephalic | | | | | | | |
| | | Trans-rectal | | | | | | | |
| | | Trans-vaginal | | | | | | | |
| | | Trans-urethral | | | | | | | |
| | | Trans-esoph. (non-Card.) | | | | | | | |
| | | Musculo-skel. (Convent.) | | | | | | | |
| | | Musculo-skel. (Superfic.) | | | | | | | |
| | | Intra-luminal | | | | | | | |
| | | Other (spec.) - Wound | | | | | | | |
| | | Other (spec.) - Gynecological | | | | | | | |
| | | Other (spec.) - Endoscopy | | | | | | | |
| | | Other (spec.) - | | | | | | | |
| Cardiac | | Cardiac Adult | | | | | | | |
| | | Cardiac Pediatric | | | | | | | |
| | | Trans-esophageal (card.) | | | | | | | |
| | | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | | Peripheral vessel | | | | | | | |
| | | Other (spec.) - | | | | | | | |
| N= new indication. P = previously cleared in K142368 | | | | | | | | | |
| *Combination of each operating mode, B, M, PWD, and Color Doppler; B/B, B/M, B/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M,<br>CFM-B/PW | | | | | | | | | |
| **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Contrast Imaging | | | | | | | | | |
| Additional Comments: | | | | | | | | | |
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | | |
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | | |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | | |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | | | | | | | | |
| Subscript "f": | Includes imaging for guidance of trans-vaginal biopsy. | | | | | | | | |
| Subscript "g": | For Adult and Pediatric patients. | | | | | | | | |
| Subscript "h": | Includes imaging for Cavernous/Non-Cavernous wounds | | | | | | | | |

### (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

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| | | DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM | | | | | | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|----|-----|-----|------------------|----------------------|--------------------|
| System: | Noblus | | | | | | | |
| Transducer: | C22T | | | | | | | |
| | 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<br>Doppler | Combined*<br>(Spec.) | Other**<br>(Spec.) |
| (Track I only) | (Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | P | P | P | | P | P | P |
| | Intra-operative (Spec.) | Pb | Pb | Pb | | Pb | Pb | Pb |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Tra…