K193262 is an FDA 510(k) clearance for the DR 600 with Tomosynthesis. This device is classified as a System, X-ray, Tomographic (Class II - Special Controls, product code IZF).
Submitted by Agfa N.V. (Mortsel, BE). The FDA issued a Cleared decision on March 9, 2020, 104 days after receiving the submission on November 26, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1740.
| 510(k) Number | K193262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2019 |
| Decision Date | March 09, 2020 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZF - System, X-ray, Tomographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1740 |