# K222864: 8MP Color LCD Monitor CL-R813

- Pathway: 510(k) (Traditional)
- Applicant: Jvckenwood Corporation
- Decided: Dec 21, 2022 after 90 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: 7 generations back to K000293 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182539: 2MP Color LCD Monitor CL-R211, Jvckenwood Corporation (2018) Summary page 4.

## Indications for use
CL-R813 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.

Source page: https://510kreport.com/device/K222864
Methodology: https://510kreport.com/methodology