K222208 is an FDA 510(k) clearance for the Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D. This device is classified as a Display, Diagnostic Radiology (Class II - Special Controls, product code PGY).
Submitted by Qingdao Hisense Medical Equipment Co., Ltd. (Qingdao, CN). The FDA issued a Cleared decision on November 17, 2022, 115 days after receiving the submission on July 25, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050. The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners..
| 510(k) Number | K222208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2022 |
| Decision Date | November 17, 2022 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | PGY - Display, Diagnostic Radiology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |
| Definition | The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners. |