K141346 is an FDA 510(k) clearance for the SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD. This device is classified as a Camera, Multi Format, Radiological (Class II - Special Controls, product code LMC).
Submitted by Sony Electronics, Inc. (Marlborough, US). The FDA issued a Cleared decision on June 26, 2014, 35 days after receiving the submission on May 22, 2014.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2040.
| 510(k) Number | K141346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2014 |
| Decision Date | June 26, 2014 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LMC - Camera, Multi Format, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2040 |