# K974423: Ultra-Vision Mammography Detail, Ultra-Vision Mammography Fast Detail

- Pathway: 510(k) (Traditional)
- Applicant: Sterling Diagnostic Imaging, Inc.
- Decided: Dec 22, 1997 after 28 days
- Product code: EAM (Screen, Intensifying, Radiographic)
- Device class: 1
- Regulation: 21 CFR 892.1960
- 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) Microvision™ Detail: named in the summary without a submission number

## Indications for use
These radiographic intensifying screens have application whenever a high image quality radiographic examination such as mammography is required.

Source page: https://510kreport.com/device/K974423
Methodology: https://510kreport.com/methodology