# K151007: 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)

- Pathway: 510(k) (Traditional)
- Applicant: Jvckenwood Corporation
- Decided: May 8, 2015 after 23 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: 9 generations back to K913770 (1991). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131137: 21.3 Inch Monochrome Digital Mammography LCD Monitor MS55I2 (ML21055, MD211G5), Jvckenwood Corporation (2013) Summary page 4.

## Indications for use
21.3 inch (54 cm) inch Color Digital Mammography 5M pixel LCD Monitor CCL550i2 (CL21550) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

Source page: https://510kreport.com/device/K151007
Methodology: https://510kreport.com/methodology