# K953398: Uniscan

- Pathway: 510(k) (Traditional)
- Applicant: Merlin Engineering Works, Inc.
- Decided: Oct 6, 1995 after 78 days
- Product code: LMD (System, Digital Image Communications, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 5 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K974882: Downscan LT (1998), 0 descendants of its own
- K971154: Multipics (ME-977) (1997), 0 descendants of its own
- K971153: Splitscreen (ME-975) (1997), 0 descendants of its own
- K970451: Downscan 120 (1997), 0 descendants of its own
- K970450: Upscan 120 (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K953398
Methodology: https://510kreport.com/methodology