K960635 is an FDA 510(k) clearance for the PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMS. This device is classified as a System, X-ray, Tomography, Computed (Class II - Special Controls, product code JAK).
Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on April 3, 1996, 49 days after receiving the submission on February 14, 1996.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750.
| 510(k) Number | K960635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 1996 |
| Decision Date | April 03, 1996 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAK — System, X-ray, Tomography, Computed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1750 |