UPACS

K960941 · Base Ten Systems, Inc. · LMB · Jun 3, 1996 · Radiology

Device Facts

• Record ID: K960941
• Device Name: UPACS
• Applicant: Base Ten Systems, Inc.
• Product Code: LMB · Radiology
• Decision Date: Jun 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2010
• Device Class: Class 1

Intended Use

uPACS™ is a software controlled microprocessor based archiving system using installed proprietary software for recording, storage and presentation of video ultrasound images. The system is designed for use with FDA approved ultrasound imaging equipment which provides video output and is approved for operation and use in the patient environment.

Device Story

uPACS is a software-controlled, microprocessor-based archiving system; interfaces with FDA-cleared ultrasound scanners via NTSC/PAL video output. System captures, displays, and stores single-frame ultrasound images and associated text on an IBM-compatible PC. Features include live image viewing, image/text editing, multi-image display (up to four), image annotation, CD-ROM archiving, and export to diskette or printer. Operated by clinical staff in patient environments; provides secure access control. Facilitates image review and documentation; supports clinical workflow by enabling permanent storage and retrieval of diagnostic ultrasound data.

Clinical Evidence

No clinical data; substantial equivalence determination is not based on an assessment of performance data.

Technological Characteristics

Microprocessor-based system; IBM-compatible PC platform; NTSC/PAL video input; CD-ROM storage; diskette/printer export; software-controlled image capture and display; security access control.

Indications for Use

Indicated for recording, storage, and presentation of video ultrasound images from FDA-cleared ultrasound scanners in clinical environments.

Regulatory Classification

Identification

A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.

Predicate Devices

• Intrascan
• Instrascan II

Submission Summary (Full Text)

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K960941

510(k) Summary
(In accordance with 21 CFR 807.92)
Device: uPACS™

A.

JUN - 3 1996

K960941

## 1. Submittals:

Base Ten Systems, Inc.
One Electronics Drive
Trenton, New Jersey 08619-0151
Voice: [phone]
Fax: [phone]
Contact Person: Richard J. Farrelly
Date of Preparation: 13 May 1996

## 2. Name of Device:

Trade or Proprietary Name: uPACS™
Company or Usual Name: Picture Archiving System
(Established Name)
Classification Name: Device, Digital Image Storage - 90LMB
Digitzer, Image - 90LMA

## 3. Predicate Devices:

Intrascan
and
Instrascan II

Manufactured by:
Mark Solutions, Inc.
Mark Care Medical Systems, Inc.
87 Route 17 North
Maywood, New Jersey 07607
Telephone: [phone]

## 4. Device Description:

uPACS is a software controlled microprocessor based archiving system using installed proprietary software for recording, storage and presentation of video ultrasound images. The system is designed for connection to and use with FDA cleared ultrasound imaging equipment which provides video output and is cleared for operation and use in the patient environment.

In the uPACS standard configuration, an FDA approved ultrasound imaging device (scanner) is connected to an IBM-compatible personal computer (PC). Images captured by

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the scanner are displayed on the monitor of the PC along with any text that is typed on the PC keyboard. The ultrasound image and patient text data can be stored on a CD-ROM in the PC, and images can be exported to an FDA approved printer by the PC.

uPACS enables users to perform the following system functions:

- View live images from user provided FDA approved ultrasound scanners or other NTSC or PAL video sources;
- Capture single-frame images from ultrasound scanners or other NTSC or PAL video sources;
- Obtain text data directly from captured images;
- Edit text and image data before permanent storage;
- Review stored images on the system and on CD-ROM;
- Display up to four images at a time for review;
- Place notations directly on images;
- Archive images using CD-ROM;
- Export images to diskette and user provided printer(s);
- Provide a means for user training and proficiency demonstration;
- Assign security privileges to specific users in accordance with clinical access criteria.

## 5. Intended Use Statement:

uPACS™ is a software controlled microprocessor based archiving system using installed proprietary software for recording, storage and presentation of video ultrasound images. The system is designed for use with FDA approved ultrasound imaging equipment which provides video output and is approved for operation and use in the patient environment.

## 6. The technological characteristics of the uPACS™ Device are essentially the same as that of the predicate device.

## B. The determination of substantial equivalence is not based on an assessment of performance data.

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