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510(k) K160347

Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 by Qingdao Hisense Medical Equipment Co., Ltd. — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2016
Date Received
February 8, 2016
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.

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  • K222132 — Hisense LCD monitor HMD2G21S, HMD3G21S (November 8, 2022)
  • K221567 — LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) (July 26, 2022)
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  • K152030 — Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) (September 16, 2015)
  • K151709 — Hi-Light Diagnostic Ultrasound Systems (July 17, 2015)

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