Submission Details
| 510(k) Number | K082458 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 26, 2008 |
| Decision Date | October 17, 2008 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
P3T ABDOMEN
Oct 2008
Decision
52d
Days
Class 2
Risk
About This 510(k) Submission
K082458 is an FDA 510(k) clearance for the P3T ABDOMEN, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on October 17, 2008, 52 days after receiving the submission on August 26, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.
Device Classification
| Product Code | JAK — System, X-ray, Tomography, Computed |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1750 |
Manufacturer
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