Submission Details
| 510(k) Number | K060550 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 02, 2006 |
| Decision Date | March 31, 2006 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Special
KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386
Mar 2006
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K060550 is an FDA 510(k) clearance for the KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on March 31, 2006, 29 days after receiving the submission on March 2, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.
Device Classification
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1680 |
Manufacturer
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