# K203733: 12MP Color Digital Mammography LCD Monitor CL-S1200

- Pathway: 510(k) (Traditional)
- Applicant: Jvckenwood Corporation
- Decided: Jun 29, 2021 after 190 days
- Product code: PGY (Display, Diagnostic Radiology)
- 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: 4 generations back to K103792 (2011). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191137: 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500, Jvckenwood Corporation (2019) Summary page 4.

## Indications for use
CL-S1200 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

Source page: https://510kreport.com/device/K203733
Methodology: https://510kreport.com/methodology