K183448 is an FDA 510(k) clearance for the NewTom 5G XL. This device is classified as a System, X-ray, Tomography, Computed (Class II - Special Controls, product code JAK).
Submitted by Cefla S.C. (Imola (Bo), IT). The FDA issued a Cleared decision on March 8, 2019, 86 days after receiving the submission on December 12, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750.
| 510(k) Number | K183448 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2018 |
| Decision Date | March 08, 2019 |
| Days to Decision | 86 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 |