TECHNOS MP, MODEL AU6

K023255 · Biosound Esaote, Inc. · IYN · Feb 11, 2003 · Radiology

Device Facts

• Record ID: K023255
• Device Name: TECHNOS MP, MODEL AU6
• Applicant: Biosound Esaote, Inc.
• Product Code: IYN · Radiology
• Decision Date: Feb 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The VPan (View Panoramic) Module is being added to the Technos™ ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology. The Technos™ ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vascular, fetal, pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic, other-urological and musculoskeletal applications.

Device Story

The VPan (View Panoramic) Module is a software feature for the Technos MP ultrasound system. It enables the creation of wide field-of-view panoramic images by splicing B-mode ultrasound frames. The operator manually moves the ultrasound probe across the anatomy; the system captures and stitches these frames into a single panoramic image. This allows physicians to better visualize and orient anatomy and pathology. The device supports linear, convex, and phased array transducers. Output includes panoramic images with capabilities for pan, zoom, rotate, and X/Y linear distance measurements. It is used in clinical settings by physicians for diagnostic imaging across various specialties.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software module for Technos MP ultrasound system. Uses spliced B-mode image reconstruction. Compatible with convex, linear, and phased array transducers. Provides X/Y linear distance measurements and image manipulation (pan, zoom, rotate).

Indications for Use

Indicated for diagnostic ultrasound imaging in cardiac, abdominal, peripheral vascular, fetal, pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic, urological, and musculoskeletal applications. Intended for use by physicians.

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

• AU6 (Technos/TechnosMP) (K014168)

Reference Devices

• Acuson Sequoia 512 FreeStyle Extended Imaging Software (K022567)

Submission Summary (Full Text)

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K023255

510(k) Addition of VPan Module to TechnosMP Ultrasound Imaging System Biosound Esaote

FEB 1 1 2003

# 510(k) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).

807.92(a)(1)

### Submitter Information

| Colleen Hittle Densmore, Official Correspondent | | |
|-------------------------------------------------|-------------------------------------------------------------------|----------|
| 8000 Castleway Drive | | |
| Indianapolis, IN 46250 | | |
| Phone: | [phone] | |
| Facsimile: | [phone] | |
| Contact Person: | Colleen Hittle Densmore | |
| Date: | January 15, 2003 | |
| 807.92(a)(2) | | |
| Trade Name: | Technos MP Ultrasound Imaging System<br>(Addition of VPan Module) | |
| Common Name: | Ultrasound Imaging System | |
| Classification Name(s): | Ultrasonic pulsed doppler imaging system | 892.1550 |
| Classification Number: | 90IYN<br>90IYO | |
| 807.92(a)(3) | | |
| | Predicate Device(s) | |
| Esaote | AU6 (Technos/TechnosMP) | K014168 |

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

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510(k) Addition of VPan Module to Technos \10 Ultrasound Imaging System Biosound Esaote

807.92(a)(5)

## Intended Use(s)

The VPan (View Panoramic) Module is being added to the Technos™ ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.

The Technos™ ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vascular, fetal, pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic, other-urological and musculoskeletal applications.

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510(k) Summary Addition of VPan Module to
Technos`ll Ultrasound Imaging System Biosound Esaote

## Comparison Chart for Substantial Equivalence

| | Acuson<br>Sequoia 512<br>FreeStyle Extended<br>Imaging Software<br>K022567 | Esaote<br>Technos/TechnosMp<br>VPan Module<br>This Submission |
|--------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Scanning Method | Manual movement of probe<br>across anatomy to be<br>imaged | Manual movement of probe<br>across anatomy to be<br>imaged |
| Intended Use | Provides panoramic, wide<br>field-of-view images for<br>easier orientation of<br>anatomy & pathology | Provides panoramic, wide<br>field-of-view images for<br>easier orientation of<br>anatomy & pathology |
| Measurements | X, Y Linear distances | X, Y Linear distances |
| Image Manipulation | Pan / zoom / rotate | Pan / zoom / rotate |
| Transducer types | All general imaging<br>transducers | Convex / Linear / Phased<br>Array |
| Image Format | Spliced B-mode | Spliced B-mode |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2003

Ms. Colleen Densmore Official Correspondent Biosound Esaote, Inc. 8000 Castleway Drive INDIANAPOLIS IN 46250 Re: K023255

Trade/Device Name: Technos MP Ultrasound Imaging System Addition of VPan Module Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYN and IYO Dated: January 15, 2003 Received: January 16, 2003

Dear Ms. Densmore:

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.

If vour 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): 1023 255-8

Device Name:

Indications for Use:

The VPan (View Panoramic) Module is being added to the TechnosMP ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.

The Technost 10 ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vascular, fetal, pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic, other-urological and musculoskeletal applications.

*Prescription Use*

David A. Seayom

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

Concurrence of CDRH, Office of Device Evaluation (ODE)