K231420 is an FDA 510(k) clearance for the Aura 10 PET/CT. This device is classified as a Cabinet, Emission Computed Tomography System (Class II - Special Controls, product code QXL).
Submitted by Xeos Medical (Gent, BE). The FDA issued a Cleared decision on August 10, 2023, 86 days after receiving the submission on May 16, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1200. Obtain Emission Computed Tomography (pet, Spect Or Gamma Camera) With Or Without X-ray (e.g., Ct) Imaging Of Harvested Specimens From Various Anatomical Regions In Order To Provide Verification That The Correct Tissue Has Been Excised During Surgical Procedures.
| 510(k) Number | K231420 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2023 |
| Decision Date | August 10, 2023 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | QXL - Cabinet, Emission Computed Tomography System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1200 |
| Definition | Obtain Emission Computed Tomography (pet, Spect Or Gamma Camera) With Or Without X-ray (e.g., Ct) Imaging Of Harvested Specimens From Various Anatomical Regions In Order To Provide Verification That The Correct Tissue Has Been Excised During Surgical Procedures |