Home / 510(k) Clearances / K152030

510(k) K152030

Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) by Qingdao Hisense Medical Equipment Co., Ltd. — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2015
Date Received
July 22, 2015
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.

  • K233841 — HD80 Series Ultrasound Diagnostic System (May 16, 2024)
  • K233439 — HD60 Series Ultrasound Diagnostic System (February 21, 2024)
  • K222208 — Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D (November 17, 2022)
  • K222132 — Hisense LCD monitor HMD2G21S, HMD3G21S (November 8, 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)
  • K151709 — Hi-Light Diagnostic Ultrasound Systems (July 17, 2015)

Other clearances for product code PGY

  • K252780 — LCD Monitor (CL1902A, CL2103F) (December 19, 2025)
  • K253242 — LCD Monitor (C1216W, C822W, C821W) (October 29, 2025)
  • K252030 — RadiForce GX570; RadiForce GX570-AR (August 28, 2025)
  • K243221 — RadiForce RX570; RadiForce RX570-AR (November 27, 2024)
  • K243031 — LCD Monitors C310S, G310S, C316S, G316S, C616W (October 25, 2024)
  • K242008 — Coronis OneLook (August 2, 2024)
  • K241105 — 3MP Color LCD Monitor (CL-S301) (August 1, 2024)
  • K241441 — RadiForce RX670; RadiForce RX670-AR (July 16, 2024)
  • K241499 — 21.3” 5MP Color LCD Display UMD5-21B01 (June 13, 2024)
  • K233336 — 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) (May 21, 2024)