# K960941: UPACS

- Pathway: 510(k) (Traditional)
- Applicant: Base Ten Systems, Inc.
- Decided: Jun 3, 1996 after 87 days
- Product code: LMB (Device, Digital Image Storage, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Intrascan: named in the summary without a submission number
- (no number) Instrascan I1: named in the summary without a submission number

## Indications for use
uPACS™ js 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 environement.

Source page: https://510kreport.com/device/K960941
Methodology: https://510kreport.com/methodology