HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS

K153421 · Hitachi Aloka Medical America, Inc. · IYN · Jan 21, 2016 · Radiology

Device Facts

• Record ID: K153421
• Device Name: HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS
• Applicant: Hitachi Aloka Medical America, Inc.
• Product Code: IYN · Radiology
• Decision Date: Jan 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Trans-esophageal (Cardiac) - Adult/Pediatric, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications. The modes of operation of the HI VISION Ascendus are B mode, M mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Dual Doppler mode, CFI mode (Color Flow Image), Amplitude Dopper (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real-time Virtual Sonography, Real-time Tissue Elastography and Shear Wave Measurement.

Device Story

The HI VISION Ascendus is a diagnostic ultrasound system used by trained clinicians (doctors, sonographers) in clinical settings. It utilizes various ultrasound transducers to transmit energy and detect reflected echoes from the human body. A computer system processes these signals to generate images and Doppler data, which are displayed on a monitor. The device supports multiple imaging modes, including B-mode, M-mode, Pulsed/Continuous Wave Doppler, Color Flow Imaging, Tissue Doppler Imaging, 3D imaging, Real-time Virtual Sonography, Real-time Tissue Elastography, and Shear Wave Measurement. Clinicians use these outputs to perform diagnostic evaluations and guide procedures like biopsies. The system aids in clinical decision-making by providing real-time visualization of internal structures and blood flow, potentially improving diagnostic accuracy and procedural guidance.

Clinical Evidence

No clinical data was required for this submission. Substantial equivalence was demonstrated through non-clinical testing, including acoustic output measurements, biocompatibility testing per ISO 10993-1, electromagnetic compatibility, and electrical/mechanical safety testing.

Technological Characteristics

The system is a Track III diagnostic ultrasound imaging system. It utilizes various transducers (convex, linear, sector, 4D) to generate and detect ultrasound energy. It features a computer-based signal processing unit and a video display. Materials are tested for biocompatibility per ISO 10993-1. The system supports multiple modes including B, M, PW, CW, Color Doppler, and advanced imaging like Real-time Tissue Elastography and Shear Wave Measurement. It is designed for re-use with provided cleaning and disinfection instructions.

Indications for Use

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

• HI VISION Ascendus (K110673)
• Noblus (K142368)
• Siemens Acuson S2000/S3000 (K130881)

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 consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and three human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

January 21, 2016

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

Re: K153421

Trade/Device Name: HI VISION Ascendus Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: December 10, 2015 Received: December 11, 2015

Dear Ms. Van Arsdale:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [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" (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.

Michael D'Hara

For

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

Enclosure

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# Indications for Use

510(k) Number (if known)

## K153421

Device Name HI VISION Ascendus

### Indications for Use (Describe)

HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Trans-esophageal (Cardiac) - Adult/Pediatric, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.

The modes of operation of the HI VISION Ascendus are B mode, M mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Dual Doppler mode, CFI mode (Color Flow Image), Amplitude Dopper (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real-time Virtual Sonography, Real-time Tissue Elastography and Shear Wave Measurement.

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|----------------------------------------------------------|--|
|----------------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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#### HI VISION Ascendus System:

#### Transducer: All connectable probes

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

| Clinical Application | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(Spec.) | Other** (Spec.) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----|----|-----|-----|------------------|----------------------|-----------------|
| General<br>(Track 1 only) | Ophthalmic | | | | | | | |
| Ophthalmic | Fetal | P | P | P | P | P | P | P |
| | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | Pb | Pb | Pb | | Pb | Pb | Pb |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | P | P | P | | P | P | P |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | Pc | Pd | Pd | Pd |
| | Neonatal Cephalic | P | P | P | P | P | P | P |
| Fetal Imaging &<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.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | P | P |
| | Musculo-skel. (Superfic.) | P | P | P | | P | P | P |
| | Intra-luminal | | | | | | | |
| | Other (Spec.) | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| | Trans-esophageal (Card.) | Pg | Pg | Pg | Pg | Pg | Pg | Pg |
| | Other (Spec.) | | | | | | | |
| | | | | | | | | |
| Peripheral Vessel | Peripheral Vessel | P | P | P | P | P | P | P |
| | Other (Spec.) | | | | | | | |
| N= new indication P= previously cleared in K110673 | | | | | | | | |
| *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, B/CW, CFM-B/CW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW,<br>TDI-B/B, TDI-B/M, TDI-B/PW, TDI-PW/PW | | | | | | | | |
| **Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, 4D Imaging, Omni Directional M mode, Wide View, Real Time Biplane,<br>Contrast Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography, Shear Wave Measurement. | | | | | | | | |
| Additional Comments: | | | | | | | | |
| Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | | |
| Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | | |
| Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | | |
| Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | | |
| Subscript "e": Includes imaging for guidance of trans-rectal biopsy. | | | | | | | | |
| Subscript "f": Includes managing for guidance of trans-vaginal biopsy. | | | | | | | | |

Prescription Use Only (per 21 CFR 801.109)

### (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) Number: __

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#### System: HI VISION Ascendus

#### Transducer: EUP-B512

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

| Clinical Application | | | | | | | | |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----|----|-----|-----|------------------|----------------------|-----------------|
| General<br>(Track 1 only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<br>(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 &<br>Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Card.) | | | | | | | |
| | Other (Spec.) | | | | | | | |
| Peripheral Vessel | Peripheral Vessel | | | | | | | |
| | Other (Spec.) | | | | | | | |
| N= new indication P= previously cleared in K110673 | | | | | | | | |
| | | | | | | | | |
| | *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW | | | | | | | |
| | | | | | | | | |
| | **Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Contrast Imaging, Real Time Virtual Sonography. | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| Additional Comments: | | | | | | | | |
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | |
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | | | | | | | |
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | | | | | | | |
| Subscript "g": | For Adults and Pediatric patients. | | | | | | | |

Prescription Use Only (per 21 CFR 801.109)

### (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)

{5}------------------------------------------------

#### System: HI VISION Ascendus

#### Transducer: EUP-B514

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

| Clinical Application | | | | | | | | |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----|----|-----|-----|---------|----------------------|-----------------|
| General | Specific | | | | | Color | Combined*<br>(Spec.) | Other** (Spec.) |
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P |
| | Abdominal | Pa | Pa | Pa | | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging & | Adult Cephalic | | | | | | | |
| Other | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Card.) | | | | | | | |
| | Other (Spec.) | | | | | | | |
| Peripheral Vessel | Peripheral Vessel | | | | | | | |
| | Other (Spec.) | | | | | | | |
| N= new indication P= previously cleared in K110673 | | | | | | | | |
| | | | | | | | | |
| | *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/CFM-B/PW | | | | | | | |
| | ** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Virtual Sonography. | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| Additional Comments: | | | | | | | | |
| | | | | | | | | |
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis). | | | | | | | |
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | | | | | | | |
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | | | | | | | |
| Subscript "g":<br>For Adults and Pediatric patients. | | | | | | | | |

Prescription Use Only (per 21 CFR 801.109)

## (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

{6}------------------------------------------------

#### System: HI VISION Ascendus

#### Transducer: EUP-B712

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

| Clinical Application | | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----|----|-----|-----|---------|-----------|-----------------|
| General | Specific | | | | | Color | Combined* | Other** (Spec.) |
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P |
| | Abdominal | Pa | Pa | Pa | | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging & | Adult Cephalic | | | | | | | |
| Other | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Card.) | | | | | | | |
| | Other (Spec.) | | | | | | | |
| Peripheral Vessel | Peripheral Vessel | | | | | | | |
| | Other (Spec.) | | | | | | | |
| | N= new indication P= previously cleared in K110673 | | | | | | | |
| | | | | | | | | |
| | * Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM- B/CFM-M, CFM-B/PW | | | | | | | |
| | | | | | | | | |
| | ** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Contrast Imaging, Real Time Virtual Sonography. | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| Additional Comments: | | | | | | | | |
| Subscript "a":<br>Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | | |
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | | | | | | | |
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | | | | | | | |
| Subscript "g":<br>For Adults and Pediatric patients. | | | | | | | | |

Prescription Use Only (per 21 CFR 801.109)

### (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)

{7}------------------------------------------------

#### System: HI VISION Ascendus

#### Transducer: EUP-B715

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

| Clinical Application | | | | | | | | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|----|----|-----|-----|---------|-----------|-----------------|
| General | Specific | | | | | Color | Combined* | Other** (Spec.) |
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P |
| | Abdominal | Pa | Pa | Pa | | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging & | Adult Cephalic | | | | | | | |
| Other | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Card.) | | | | | | | |
| | Other (Spec.) | | | | | | | |
| Peripheral Vessel | Peripheral Vessel | | | | | | | |
| | Other (Spec.) | | | | | | | |
| | N= new indication P= previously cleared in K110673 | | | | | | | |
| | | | | | | | | |
| | *Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/PW | | | | | | | |
| | | | | | | | | |
| | ** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Wide View, Real Time Biplane, Contrast Imaging, Real Time Virtual Sonography. | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| Additional Comments: | | | | | | | | |
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). | | | | | | | |
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | | | | | | | |
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | | | | | | | |
| Subscript "g": | For Adults and Pediatric patients. | | | | | | | |

Prescription Use Only (per 21 CFR 801.109)

### (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)

{8}------------------------------------------------

#### System: HI VISION Ascendus

Transducer: EUP-C511

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

| Clinical Application | | | | | | | | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------|----|----|-----|-----|---------|-----------|-----------------|
| General | Specific | | | | | Color | Combined* | Other** (Spec.) |
| (Track 1 only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P |
| | Abdominal | Pa | Pa | Pa | | Pa | Pa | Pa |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging & | Adult Cephalic | | | | | | | |
| Other | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Spec.) | | | | | | | |
| | Cardiac Adult | P | P | P | | P | P | P |
| Cardiac | Cardiac Pediatric | P | P | P | | P | P | P |
| | Trans-esophageal (Card.) | | | | | | | |
| | Other (Spec.) | | | | | | | |
| Peripheral Vessel | Peripheral Vessel | P | P | P | | P | P | P |
| | Other (Spec.) | | | | | | | |
| | N= new indication P= previously cleared in K110673 | | | | | | | |
| | | | | | | | | |
| | * Combination of each operating mode, B, M, PWD, and Color Doppler, B/B, B/M, B/PW, PW/PW, CFM-B/CFM-B, CFM-B/CFM-M, CFM-B/CFM-B/PW | | | | | | | |
| | | | | | | | | |
| | ** Amplitude Doppler (Color Flow Angiography), 3D Imaging, Omni Directional M mode, Wide View, Real Time Biplane, | | | | | | | |
| | Contrast Imaging, Real Time Virtual Sonography. | | | | | | | |
| | | | | | | | | |
| Additional Comments: | | | | | | | | |
| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis). | | | | | | | |
| Subscript "b": | Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). | | | | | | | |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. | | | | | | | |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. | | | | | | | |
| Subscript "e": | Includes imaging for guidance of trans-rectal biopsy. | | | | | | | |
| Subscript "f": | Includes managing for guidance of trans-vaginal biopsy. | | | | | | | |
| Subscript "g": | For Adults and Pediatric patients. | | | | | | | |

Prescription Use Only (per 21 CFR 801.109)

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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)

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#### System: HI VISION Ascendus

#### Transducer: EUP-C514

Intended Use: Diagnostic ultrasound imaging or find flow analysis if the human body as follows:

| Clinical Application | | | | | | | | |
|-…