NOBLUS DIAGNOSTIC ULTRASOUND SCANNER

K142368 · Hitachi Aloka Medical, Ltd. · IYN · Jan 14, 2015 · Radiology

Device Facts

• Record ID: K142368
• Device Name: NOBLUS DIAGNOSTIC ULTRASOUND SCANNER
• Applicant: Hitachi Aloka Medical, Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jan 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Noblus Ultrasound Diagnostic System is a portable diagnostic 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 video monitor. The system supports multiple imaging modes, including B-mode, M-mode, PW/CW Doppler, Color Doppler, TDI, 3D/4D imaging, and Real Time Tissue Elastography (RTTE) with a strain ratio feature. The RTTE feature assists in visualizing tissue hardness to aid in identifying tumors or masses. The device is powered by a standard Lithium-ion battery for portability. Clinicians use the output to assist in clinical diagnosis and decision-making, such as guiding biopsies or evaluating disease states. The system benefits patients by providing non-invasive diagnostic imaging and fluid flow analysis.

Clinical Evidence

Bench testing only. The device was evaluated for acoustic output, biocompatibility (ISO 10993-1), cleaning/disinfection effectiveness, electromagnetic compatibility, and electrical/mechanical safety. No clinical data was required.

Technological Characteristics

Portable ultrasound system with transducers, computer processing unit, Lithium-ion battery, and video monitor. Supports B, M, PW, CW, Color Doppler, TDI, 3D/4D, and Real Time Tissue Elastography (RTTE) with strain ratio. Materials tested per ISO 10993-1. Track 3 system. Connectivity includes optional image recorder.

Indications for Use

Indicated for diagnostic ultrasound evaluation of abdominal, cardiac, intra-operative, trans-esophageal, wound, fetal, pediatric, small organ, peripheral vessel, biopsy, trans-rectal, trans-vaginal, musculoskeletal, neonatal/adult cephalic, endoscopic, intraluminal, 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

• Hitachi Noblus™ Diagnostic Ultrasound System (K130308)
• HI VISION ASCENDUS Diagnostic Ultrasound Scanner (K110673)
• Siemens Medical Solutions USA, Inc. (K130881)
• Hudson 2060 Ultrasound Scanner (K022928)

Submission Summary (Full Text)

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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

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# 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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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)

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System: Noblus

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 | 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<br>& 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<br>Vessel | Peripheral vessel | P | P | P | P | P | P | P |
| | Other (spec.) | | | | | | | |
| N = new indication. P = previously cleared in K130308<br>*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.<br>**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

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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<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 | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>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":<br>Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | | | |
| Subscript "b":<br>Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | | | |
| Subscript "c":<br>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

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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 | Mode of Operation | | | | | | | |
|---------------------------|--------------------------------------|----|----|-----|-----|---------------|----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color Doppler | Combined*<br>(Spec.) | Other**<br>(Spec.) |
| | Ophthalmic | P | P | P | | P | P | P |
| | Fetal | | | | | | | |
| | Abdominal<br>Intra-operative (Spec.) | Pa | Pa | Pa | | Pa | Pa | Pa |
| | 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 | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>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

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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<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 |
| | 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<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 | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>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

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Noblus System:

C251 Transducer:

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

| Specific<br>PWD<br>CWD<br>Combined*<br>Other**<br>General<br>B<br>M<br>Color<br>(Track I only)<br>Doppler<br>(Tracks I & III)<br>(Spec.)<br>(Spec.)<br>Ophthalmic<br>Ophthalmic<br>Fetal<br>P<br>P<br>P<br>P<br>P<br>P<br>Abdominal<br>Pa<br>Pa<br>Pa<br>Pa<br>Pa<br>Pa<br>Intra-operative (Spec.)<br>Intra-operative (Neuro.)<br>Laparoscopic<br>P<br>P<br>P<br>P<br>P<br>P<br>Pediatric<br>Small Organ (Spec.)<br>Pd<br>Pd<br>Pd<br>Pd<br>Pd<br>Pd<br>Neonatal Cephalic<br>Adult Cephalic<br>Fetal Imaging<br>& Other<br>Trans-rectal<br>Trans-vaginal<br>Trans-urethral<br>Trans-esoph. (non-Card.)<br>Musculo-skel. (Convent.)<br>Musculo-skel. (Superfic.)<br>Intra-luminal<br>Other (spec.) - Wound<br>Cardiac Adult<br>Cardiac Pediatric<br>Cardiac<br>Trans-esophageal (card.)<br>Other (spec.)<br>Peripheral<br>Peripheral vessel<br>Vessel<br>Other (spec.)<br>N = new indication. P = previously cleared in K134016 & K140443<br>*Combination of each operating mode, B, M, PWD and Color Doppler. | Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--|-------------------|--|--|--|--|--|--|--|
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| ** Amplitude Doppler (Color Flow Angiography), 3D Imaging | | | | | | | | | | |
| Additional Comments: | | | | | | | | | | |
| Subscript "a":<br>Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis). | | | | | | | | | | |
| Subscript "b":<br>Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).…