# K970451: Downscan 120

- Pathway: 510(k) (Traditional)
- Applicant: Merlin Engineering Works, Inc.
- Decided: Apr 7, 1997 after 60 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953398 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953398: Uniscan, Merlin Engineering Works, Inc. (1995) Summary page 1.

## Indications for use
The intended use for DownScan 120 is conversion of X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and ultrasound images either directly from their source, or from an intermediate storage device (like a video tape or video disk), for use on display monitors, optical, tape or disk recorders, or other apparatus requiring a standard frame rate video signal (30 or 25 frames/second). The use of DownScan 120 is indicated whenever the source and destination of a video signal are incompatible due to different line and/or frame rates, and a standard frame rate video signal is required. DownScan 120 is intended for use in patient care areas, but is not intended to have any patient contact.

Source page: https://510kreport.com/device/K970451
Methodology: https://510kreport.com/methodology