Submission Details
| 510(k) Number | K083522 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 26, 2008 |
| Decision Date | January 09, 2009 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
SONY UP-DF750 DIGITAL FILM IMAGER
Jan 2009
Decision
44d
Days
Class 2
Risk
About This 510(k) Submission
K083522 is an FDA 510(k) clearance for the SONY UP-DF750 DIGITAL FILM IMAGER, a Camera, Multi Format, Radiological (Class II — Special Controls, product code LMC), submitted by Sony Electronics, Inc. (North Attleboro, US). The FDA issued a Cleared decision on January 9, 2009, 44 days after receiving the submission on November 26, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2040.
Device Classification
| Product Code | LMC — Camera, Multi Format, Radiological |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.2040 |
Manufacturer
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