510(k) K222132
K222132 is an FDA 510(k) premarket notification submitted by Qingdao Hisense Medical Equipment Co., Ltd. for the device "Hisense LCD monitor HMD2G21S, HMD3G21S". The FDA issued a decision of Substantially Equivalent on November 8, 2022. The device falls under product code PGY (Display, Diagnostic Radiology), a Class II device regulated under 21 CFR 892.2050. Qingdao Hisense Medical Equipment Co., Ltd. has at least 8 other 510(k) clearances on record.
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.