Submission Details
| 510(k) Number | K242678 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 06, 2024 |
| Decision Date | October 01, 2024 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Special
Definium Pace Select ET
Oct 2024
Decision
25d
Days
Class 2
Risk
About This 510(k) Submission
K242678 is an FDA 510(k) clearance for the Definium Pace Select ET, 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 October 1, 2024, 25 days after receiving the submission on September 6, 2024. 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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