K244016 is an FDA 510(k) clearance for the iPETcertum (v1.0). This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Claritas Healthtech Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on August 5, 2025, 221 days after receiving the submission on December 27, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K244016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2024 |
| Decision Date | August 05, 2025 |
| Days to Decision | 221 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |