Submission Details
| 510(k) Number | K231892 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 28, 2023 |
| Decision Date | September 12, 2023 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
Definium Pace Select
Sep 2023
Decision
76d
Days
Class 2
Risk
About This 510(k) Submission
K231892 is an FDA 510(k) clearance for the Definium Pace Select, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Ge Hualun Medical Systems Co. , Ltd. (Beijing, CN). The FDA issued a Cleared decision on September 12, 2023, 76 days after receiving the submission on June 28, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.
Device Classification
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1680 |
Manufacturer
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