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510(k) K231170

C350/C350G LCD Monitor; M550/M550G LCD Monitor by Nanjing Jusha Display Technology Co., Ltd. — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2023
Date Received
April 25, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Diagnostic Radiology
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.

Other clearances by Nanjing Jusha Display Technology Co., Ltd.

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  • K183496 — JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Mon (April 8, 2019)
  • K183494 — R190/R191 LCD Monitor (April 5, 2019)

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