K242499 is an FDA 510(k) clearance for the Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)). This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Shenzhen?Sontu?Medical?Imaging?Equipment?Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 6, 2025, 137 days after receiving the submission on August 22, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K242499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2024 |
| Decision Date | January 06, 2025 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPR - System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |