K152030 is an FDA 510(k) clearance for the Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21). This device is classified as a Display, Diagnostic Radiology (Class II - Special Controls, product code PGY).
Submitted by Qingdao Hisense Medical Equipment Co., Ltd. (Qing Dao, CN). The FDA issued a Cleared decision on September 16, 2015, 56 days after receiving the submission on July 22, 2015.
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 | K152030 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2015 |
| Decision Date | September 16, 2015 |
| Days to Decision | 56 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. |