# K200161: 3MP Monochrome Digital Mammography LCD Monitor MS-S300

- Pathway: 510(k) (Traditional)
- Applicant: Jvckenwood Corporation
- Decided: Feb 21, 2020 after 30 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: 11 generations back to K913770 (1991). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133686: 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035), Jvckenwood Corporation (2014) Summary page 4.

## Indications for use
MS-S300 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/K200161
Methodology: https://510kreport.com/methodology