UPACS

{0} 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: (609) 586-7010 Fax: (609) 586-1593 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: (201) 368-8118 ## 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 Page 3 {1} 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. Page 4