# K231170: C350/C350G LCD Monitor; M550/M550G LCD Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nanjing Jusha Display Technology Co., Ltd.
- Decided: Jun 7, 2023 after 43 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 K092613 (2010). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183498: JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor, Nanjing Jusha Display Technology Co., Ltd. (2019) Summary page 5.
- K161229: Mammo Tomosynthesis (MDMG-5221), Barco N.V. (2016) Summary page 5.

## Indications for use
C350G/C350/JUSHA-C350G/JUSHA-C350 LCD monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system. M550G/ M550 /JUSHA-M550G/JUSHA-M550 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially de displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

Source page: https://510kreport.com/device/K231170
Methodology: https://510kreport.com/methodology