# K971153: Splitscreen (ME-975)

- Pathway: 510(k) (Traditional)
- Applicant: Merlin Engineering Works, Inc.
- Decided: Jun 25, 1997 after 89 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
Longest line of descent: 1 generation back to K920550 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K920550: Display Processor - Model IDP5100, Perkins Mfg. Co. (1992) Summary page 1.

## Indications for use
The use of SplitScreen is indicated whenever two images are required to be shown together side-by-side in a single image/display, and a high-line rate (e.g., 1049 lines @ 30 frames/sec. or 1249 lines @ 25 fps) video signal is required. Examples include conversion / combining of X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and/or 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, disk, or other apparatus requiring a high-line rate video signal.

Source page: https://510kreport.com/device/K971153
Methodology: https://510kreport.com/methodology