HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS

K093466 · Hitachi Medical Systems America, Inc. · IYO · Jun 17, 2010 · Radiology

Device Facts

• Record ID: K093466
• Device Name: HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS
• Applicant: Hitachi Medical Systems America, Inc.
• Product Code: IYO · Radiology
• Decision Date: Jun 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The HI VISION Preirus is intended for use by trained personnel (doctor, songrapher, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac. Intra-operative. Fetal. Pediatric. Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications. The Modes of Operation of the HI VISION Preirus are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography..

Device Story

The Hitachi HI VISION Preirus is a diagnostic ultrasound scanner used by trained clinicians (doctors, sonographers) in clinical settings. It utilizes ultrasound transducers to emit acoustic energy (1-20 MHz) into the body and detect reflected echoes. The system's computer processes these signals to generate images or Doppler data, displayed on a monitor. It supports multiple modes including B, M, PW/CW Doppler, Color Doppler, Amplitude Doppler, TDI, 3D/4D imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography. The device aids in clinical decision-making by providing diagnostic visualization of internal structures and fluid flow, facilitating procedures like biopsies and surgical guidance. It benefits patients by enabling non-invasive diagnostic assessment and procedural guidance.

Clinical Evidence

Bench testing only. Verification activities included electrical and mechanical safety (IEC60601-1), acoustic output safety (IEC60601-2-37), software verification, and biocompatibility testing (ISO10993) for patient-contact materials. No clinical data was required for this 510(k) submission.

Technological Characteristics

System consists of ultrasound transducers, computer control/processing unit, and video monitor. Operates at 1-20 MHz. Materials comply with ISO10993. Connectivity includes standard ultrasound imaging interfaces. Software is embedded firmware. Sterilization/disinfection follows standard clinical protocols for ultrasound probes.

Indications for Use

Indicated for diagnostic ultrasound evaluation of abdominal, cardiac, intra-operative, fetal, pediatric, small organ, peripheral vessel, biopsy, trans-rectal, trans-vaginal, musculoskeletal, neonatal/adult cephalic, endoscopic, intra-luminal, gynecological, urological, and laparoscopic applications in patients requiring diagnostic ultrasound imaging or fluid flow analysis.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• HI VISION 900 Diagnostic Ultrasound Scanner (K063518)
• GE Logiq® E9 (K082185)
• Acuson S2000 (K072786)

Submission Summary (Full Text)

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JUN 1 7 2010

## Submitter Information

| Submitter: | Hitachi Medical Systems America, Inc.<br>1959 Summit Commerce Park<br>Twinsburg, Ohio 44087-2371<br>ph: [phone]<br>fax: [phone] | K093466 |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Contact: | Douglas J. Thistlethwaite | |
| Date: | April 26, 2010 | |

## Device Name

| Classification Name: | System, Imaging, Pulsed Doppler, Ultrasonic | |
|-------------------------|-----------------------------------------------------------------------------------------------------------|--|
| Classification Number: | 90-IYN | |
| Trade/Proprietary Name: | HITACHI HI VISION Preirus Diagnostic Ultrasound Scanner | |
| Predicate Device(s): | HI VISION 900 Diagnostic Ultrasound Scanner (K063518)<br>GE Logiq® E9 (K082185)<br>Acuson S2000 (K072786) | |

## Device Intended Use

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

The Modes of Operation of the HI VISION Preirus are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography..

# Device Description

## Function

An ultrasound system consists of the following:

- Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the . reflected echoes
- . A computer system to control the transducer and analyze the signals resulting from the reflected echoes
- A video monitor with optional image recorder to display the computed image or derived . Doppler data

## Scientific Concepts

An acoustic wave is a mechanical perturbation of a medium which passes through a given medium at a fixed velocity. The rate at which the particles in the medium vibrate in the disturbance is the frequency of the wave, and is measure as cycles/second, or hertz (Hz). Frequencies above 20 kHz are not audible, and above this frequency, the acoustic energy is known as ultrasound. For the purposes of medical ultrasound imaging, frequencies in the range of 1-20 MHz are utilized.

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The ultrasound waves comprising a beam travel in as straight line in homogeneous media. When an ultrasound wave reaches an interface between two media of different impedances, a portion of the beam energy may pass through the boundary (transmission), and a portion may be reflected. The direction of propagation of the transmitted beam is determined by the angle of incidence of the incident beam upon the boundary, and differences (if any) in the speed of sound in the two media. The direction of reflection is determined solely by the angle of incidence upon the boundary. The relative strength of the reflected wave depends upon the differences in the impedances between the two media. Reflection at a boundary between soft tissue and bone, as an example, involves a large impedance difference, and results in a relatively strong reflected echo. Reflection at a boundary between two soft tissue-types with a relatively small impedance difference, on the other hand, results in a relatively weak reflected echo.

The ultrasound transducer, when operating in pulsed mode, periodically emits an ultrasound burst at a predetermined rate described as the pulse repetition frequency (PRF). During the time duration that the transducer is not transmitting ultrasound energy, it may act as a received for the reflected ultrasound energy. Since the speed of propagation of ultrasound in tissues is estimated as 1540m/sec, the time elapsed between transmission of a pulse and receipt of an echo may be used to estimate the distance from the transducer to the tissue structure giving rise to the reflected echo. The relative strength of the reflected echo can be used to determine the brightness of display of the reflected echo or strength of derived Doppler signal.

### Physical and Performance Characteristics

The principle of operation of ultrasound imaging involves generation of an ultrasound wave with an electric signal applied to a transducer, direction of the resulting ultrasound wave into the tissue of the body, and reception and analysis of the echoes reflected back to the same or an adjacent transducer from the various tissues along the path of the ultrasound wave.

# Device Technological Characteristics

The technological characteristics of this device are identical to the primary predicate device. The control and image processing hardware and the base elements of the system software are identical to the predicate device. See Section 4 - Predicate Device Comparison.

## Conclusions

It is the opinion of Hitachi Medical Systems America, Inc. that HITACHI HI VISION Preirus Diagnostic Ultrasound Scanner is substantially equivalent to the predicate devices. In addition, we have concluded that the subject system is:

- . Substantially equivalent with respect to safety, effectiveness, and functionality to the HI VISION 900 Diagnostic Ultrasound Scanner (K063518) with the exception of the two new Modes of Operation, Real Time Tissue Elastography and Real Time Virtual Sonography.
- Substantially equivalent with respect to safety and functionality to the GE Logiq® E9 . (K082185) in regards to the device with Real-time Virtual Sonography (RVS)
- Substantially equivalent with respect to safety and functionality to the Acuson S2000 . (K072786) in regards to the device with Real-time Tissue Elastography

## Attachment

| ATTACHMENT | POSITION |
|------------------------------------------------|----------|
| Declaration of Conformity with Design Controls | 1 |

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## Summary of Design Control Activities

| Items | Tests performed |
|---------------------------------|------------------------------------|
| Electrical, Mechanical safety | IEC60601-11<br>See section 1.7.2.1 |
| Acoustic output safety | FDA Guidance<br>IEC60601-2-372 |
| Software | See section 1.7.5 |
| Probe patient contact materials | ISO109933<br>See section 1.7.3 |

The design validation / verification tests that were performed are listed.

1 Medical Electrical Equipment, Part 1: General Requirements for Safety IEC60601-1

2 Medical Electrical Equipment, Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

3 Biological Evaluation of Medical Device

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#### DECLARATION OF CONFORMITY WITH DESIGN CONTROLS

#### Verification Activities

To the best of my knowledge, the verification activities, as required by the risk analysis, for the modification were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met.

Name:

H. Noguchi

Title: Manager,

Signature:

H. Noguchi

Ultrasound QA Section, Hitachi Medical Corporation Date: March 31, 2009

#### Manufacturing Facility

The manufacturing facility, Hitachi Medical Corporation is in conformance with the design control requirements as specified in 21 CFR 820.30 and the records are available for review.

Name:

T. Kasanami

Title: Manager,

Development Design Dept., Ultrasound Systems Division, Hitachi Medical Corporation March 31, 2009 Date:

Signature:

T. Kasami

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

## JUN 1 7 2010

Mr. Doug Thistlethwaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summitt Commerce Park TWINSBURG OH 44087

Re: K093466 ·

Trade/Device Name: Hitachi HI VISION Preirus Diagnostic Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: June 11, 2010 Received: June 15, 2010

Dear Mr. Thistlethwaite:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Hitachi HI VISION Preirus Diagnostic Ultrasound Scanner, as described in your premarket notification:

### Transducer Model Numbers

EUP-B512 EUP-B514 EUP-C514 EUP-C524 EUP-C532 EUP-C715 EUP-CC531 EUP-CV524 EUP-CV714

| EUP-ES52E |
|------------------|
| EUP-L52 |
| EUP-L53 |
| EUP-L53L |
| EUP-L65 |
| EUP-L73S |
| EUP-L74M |
| EUP-O54J |
| EUP-R54AW-19--33 |

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| EUP-S50A | EUP-V53W |
|----------|---------------|
| EUP-S52 | EUP-VV731 |
| EUP-S70 | Fujinon SP711 |
| EUP-U533 | |

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

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

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at [phone].

Sincerely yours.

[signature]

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosures

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# Indications for Use

510(k) Number (if known):

Device Name: HI VISION Preirus Diagnostic Ultrasound Scanner 1

Indications For Use:

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

The Modes of Operation of the Hi VISION Preirus are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (0885) ODV D

Signature

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of

510K. K093466

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| 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 | P | P | P | P | P | P | P |
| | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| | Intra-operative (Spec.) | Pb | Pb | Pb | | Pb | Pb | Pb |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | P | P | P | | P | P | P |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | | Pd | Pd | Pd |
| | Neonatal Cephalic | P | P | P | | P | P | P |
| | Adult Cephalic | P | P | P | P | P | P | P |
| | Trans-rectal | Ph | Ph | Ph | | Ph | Ph | Ph |
| | Trans-vaginal | Pf | Pf | Pf | | Pf | Pf | Pf |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | P | P |
| | Musculo-skel. (Superfic.) | P | P | P | | P | P | P |
| | Intra-luminal | P | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | | P | | P |
| | Cardiac Pediatric | P | P | P | P | P | P | P |
| | Trans-esophageal (card.) | Pg | Pg | Pg | P | Pg | Pg | Pg |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P | P |
| | Other (spec.) | | | | | | | |

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

indication. P = previously cleared in K063518.

* Combination of each operating mode, B, M, PWD, CWD and Color Doppler.

** Amplitude Doppler (Color Flow Angiography), Tissue Doppler Imaging, 3D Imaging, 4D Imaging, Real Time Tissue Elastography, Real Time Virtual Sonography

Additional Comments:

System:

| Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures | |
|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| (including amniocentesis). | |
| Subscript "b": Includes imaging of organs and structures exposed during surgery. | |
| Subscript "b": | Includes imaging of organs and structures exposed during surgery<br>(excluding neurosurgery and laparoscopic procedures). |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Bevice Evaluation (OBE) OLUD

SARR

(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K093466

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System: Transducer: EUP-B512

| | Intended use. Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows |
|--|-------------------------------------------------------------------------------------------------|
| | |

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

N = new indication. P = previously cleared in K063518.

*Combination of each operating mode, B, M, PWD and Color Doppler.

** Amplitude Doppler (Color Flow Angiography), Real Time Virtual Songraphy

Additional Comments:

| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures<br>(including amniocentesis). |
|----------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery<br>(excluding neurosurgery and laparoscopic procedures). |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| | (PLEASE DO NOT WRITE BELOW THIS LINE) |

WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (OBE) OLL O

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diffision of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K093466

.

{9}------------------------------------------------

Transducer: EUP-B514

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

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|----|-----|-----|------------------|----------------------|--------------------|
| General<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.) | | | | | | | |
| | 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 Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N = new indication. P = previously cleared in K063518.

*Combination of each operating mode, B, M, PWD and Color Doppler.

**Amplitude Doppler (Color Flow Angiography), Real Time Virtual Sonography

.

Additional Comments:

System:

Subscript "a" Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

| Subscript "b": | Includes imaging of organs and structures exposed during surgery<br>(excluding neurosurgery and laparoscopic procedures). |
|----------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| | (PLEASE DO NOT WRITE BELOW THIS LINE COMPLETE ON SEPARATE SHEET) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (GBB) Of VD

(Division Sign Off)

(Division Sign-Off)
Division of Radiological Devices
Vitro Diagnostic Devices Excludio Division of Radiological Devices
Office of In Vitro Diagnostic Devices
Lotfice of In Vitro Diagnostic Devices Evaluation and Safety
L

510K. K093446

{10}------------------------------------------------

System: Transducer:

EUP-C514

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

| Clinical Application | | Mode of Operation | | | | | | Other**<br>(Spec.) |
|---------------------------|------------------------------|-------------------|----|-----|-----|------------------|----------------------|--------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined*<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.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N = new indication. P = previously cleared in K063518.

*Combination of each operating mode, B, M, PWD and Color Doppler.

** Amplitude Doppler (Color Flow Anging, 4D Imaging, 4D Imaging, Real Time Virtual Sonography

#### Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

| Subscript "b": | Includes imaging of organs and structures exposed during surgery<br>(excluding neurosurgery and laparoscopic procedures). |
|----------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |

Concurrence of CDRH, Office of Bevice Evaluation (ODE) - O.D. D

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K093466

{11}------------------------------------------------

System: Transducer:

EUP-C524

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

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|----|-----|-----|------------------|----------------------|--------------------|
| General<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 | 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<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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N = new indication. P = previously cleared in K063518.

*Combination of each operating mode, B, M, PWD and Color Doppler.

**Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

| Subscript "b": | Includes imaging of organs and structures exposed during surgery<br>(excluding neurosurgery and laparoscopic procedures). |
|----------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K: K093466

{12}------------------------------------------------

System: Transducer:

EUP-C532

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

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|----|-----|-----|------------------|----------------------|--------------------|
| General<br>(Track 1 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 | P | P | P | | P | P | P |
| | Small Organ (Spec.) | Pd | Pd | Pd | | Pd | Pd | Pd |
| | Neonatal Cephalic | P | P | P | | P | P | P |
| Fetal Imaging<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<br>Vessel | Peripheral vessel | P | P | P | | P | P | P |
| | Other (spec.) | | | | | | | |

N = new indication. P = previously cleared in K063518.

*Combination of each operating mode, B, M, PWD and Color Doppler.

**Amplitude Doppler (Color Flow Angiography), Real Time Tissue Elastography

Additional Comments:

| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures<br>(including amniocentesis). |
|----------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery<br>(excluding neurosurgery and laparoscopic procedures). |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ・

510K

. ',

(Division Sign-Off)

(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

{13}------------------------------------------------

System: Transducer: EUP-C715

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

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|----|-----|-----|------------------|----------------------|--------------------|
| General<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.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N = new indication. P = previously cleared in K063518.

*Combination of each operating mode, B, M, PWD and Color Doppler.

** Amplitude Doppler (Color Flow Angiography), Real Time Virtual Sonography

#### Additional Comments:

Subscript "2" Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures

| (including amniocentesis). |
|----------------------------------------------------------------------------------------------------------|
| Subscript "b": Includes imaging of organs and structures exposed during surgery |
| (excluding neurosurgery and laparoscopic procedures). |
| Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": For pediatric patients. |
| Subscript "h": Includes imaging for guidance of transrectal biopsy. |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDBOD Concurrence of CDRH, Office of Device Evaluation (ODE)

​ទាល​K

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

{14}------------------------------------------------

System: Transducer:

EUP-CC531

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

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|----|-----|-----|------------------|----------------------|--------------------|
| General<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 | | | | | | | |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Spec.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | Pe | Pe | Pe | | Pe | Pe | Pe |
| | Trans-vaginal | Pf | Pf | Pf | | Pf | Pf | Pf |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N = new indication. P = previously cleared in K063518.

*Combination of each operating mode, B, M, PWD and Color Doppler.

** Amplitude Doppler (Color Flow Angiography), Real Time Tissue Elastography

Additional Comments:

Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).

| Subscript "b": | Includes imaging of organs and structures exposed during surgery<br>(excluding neurosurgery and laparoscopic procedures). |
|----------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Dovice Evaluation (ODE)

SND

(Division Sign Off) Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K093466

{15}------------------------------------------------

System Transducer:

EUP-CV524

| Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|------------------------------|
| Minion Anningtion<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | The first for any would will be and | No. of children call a comes |

| 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 | P | P | P | | P | P | P |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Spec.) | P | P | P | | P | P | P |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N = new indication. P = previously cleared in K063518.

*Combination of each operating mode, B, M, PWD and Color Doppler.

**Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging

Additional Comments:

| Subscript "a": | Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures<br>(including amniocentesis). |
|----------------|---------------------------------------------------------------------------------------------------------------------------|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery<br>(excluding neurosurgery and laparoscopic procedures). |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy. |
| Subscript "e": | Includes imaging for guidance of transrectal biopsy. |
| Subscript "f": | Includes imaging for guidance of transvaginal biopsy. |
| Subscript "g": | For pediatric patients. |
| Subscript "h": | Includes imaging for guidance of transrectal biopsy. |

510K

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Dovice Eveluzition (ODE)

signature

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

{16}------------------------------------------------

System: Transducer:

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

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------|-------------------|---|-----|-----|------------------|----------------------|---------------------|
| General<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 | P | P | P | | P | P | P |
| | Intra-operative (Spec.) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (Spec.) | P | P | P | | P | P | P |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging | Adult Cephalic | | | | | | | |
| & Other | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) | | | | | | | |

N = new indication. P = previously cleared in K063518.

*Combination of each operating mode, B, M, PWD and Color Doppler.

**Amplitude Doppler (Color Flow Angiography), 3D Imaging, 4D Imaging

Additional Comments:

Subscript "a". Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures

| | (including amniocentesis). |
|----------------|-------------------------------------------------------------------------------------------|
| Subscript "b": | Includes imaging of organs and structures exposed during surgery |
| | (excluding neurosurgery and laparoscopic procedures). |
| Subscript "c": | Includes thyroid, parathyroid, breast, scrotum, penis. |
| Subscript "d": | Includes thyroid, parathyroi…