UPACS VERSION 1.7

K961160 · Base Ten Systems, Inc. · LMB · Jun 11, 1996 · Radiology

Device Facts

• Record ID: K961160
• Device Name: UPACS VERSION 1.7
• Applicant: Base Ten Systems, Inc.
• Product Code: LMB · Radiology
• Decision Date: Jun 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2010
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

uPACS™ Version 1.7 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 Version 1.7 is a software-controlled, microprocessor-based archiving system; captures, stores, archives, and presents video ultrasound images. Inputs: NTSC/PAL video signals from FDA-cleared ultrasound scanners or magneto-optical (MO) disks. Operation: PC-based system captures single-frame images; allows text annotation; enables multi-image display (up to four); supports CD-ROM archiving and printing. Used in clinical settings by healthcare professionals. Output: Visual display of images/text on PC monitor; exported images to diskette, MO disk, or printer. Benefits: Facilitates image review, documentation, and clinical workflow management.

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. Inputs: NTSC/PAL video signals. Storage media: CD-ROM, magneto-optical (MO) disks, diskette. Connectivity: Interfaces with FDA-cleared ultrasound scanners. Software-controlled archiving and presentation.

Indications for Use

Indicated for the recording, storage, and presentation of video ultrasound images captured from FDA-approved ultrasound imaging equipment in a clinical environment.

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 (Mark Solutions, Inc.)
• Intrascan II (Mark Care Medical Systems, Inc.)

Submission Summary (Full Text)

{0}

510(k) Summary
(In accordance with 21 CFR 807.92)
Device: uPACS™ Version 1.7
K961160

A.

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

JUN 11 1996

2. Name of Device:

Trade or Proprietary Name: uPACS™ Version 1.7
Company or Usual Name: Picture Archiving System
(Established Name)
Classification Name: Device, Digital Image Storage - 90LMB
Digitizers, 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 Version 1.7 is a software controlled microprocessor based archiving system using installed proprietary software for capturing, storage, archiving 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. uPACS Version 1.7 can also accept images stored on magneto-optical (MO) disks, captured remotely, in video output form.

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In the standard uPACS Version 1.7 configuration, an FDA cleared ultrasound imaging device (scanner) is connected to an IBM-compatible personal computer (PC) or to a remote capture unit (not part of the uPACS Version 1.7 system) which stores but does not archive images on an MO disk. Images captured by the scanner, or captured remotely and imported to uPACS Version 1.7 on an MO disk, 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 a medical quality printer by the PC.

uPACS Version 1.7 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;
- Import images, captured remotely, on an MO disk;
- 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, MO disk, 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.

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## 5. Intended Use Statement:

uPACS™ Version 1.7 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™ Version 1.7 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.