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510(k) K222132

Hisense LCD monitor HMD2G21S, HMD3G21S by Qingdao Hisense Medical Equipment Co., Ltd. — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2022
Date Received
July 19, 2022
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 Qingdao Hisense Medical Equipment Co., Ltd.

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  • K222208 — Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D (November 17, 2022)
  • K221567 — LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) (July 26, 2022)
  • K213862 — HD60 Series Ultrasound Diagnostic System (June 8, 2022)
  • K160347 — Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 (March 3, 2016)
  • K152030 — Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) (September 16, 2015)
  • K151709 — Hi-Light Diagnostic Ultrasound Systems (July 17, 2015)

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