K151134 is an FDA 510(k) clearance for the 21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210). This device is classified as a Display, Diagnostic Radiology (Class II - Special Controls, product code PGY).
Submitted by Jvckenwood Corporation (Yokohama, JP). The FDA issued a Cleared decision on May 27, 2015, 28 days after receiving the submission on April 29, 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 | K151134 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2015 |
| Decision Date | May 27, 2015 |
| Days to Decision | 28 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. |