Submission Details
| 510(k) Number | K220518 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 23, 2022 |
| Decision Date | April 01, 2022 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
SKANRAD 400
Apr 2022
Decision
37d
Days
Class 2
Risk
About This 510(k) Submission
K220518 is an FDA 510(k) clearance for the SKANRAD 400, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Skanray Technologies Limited (Mysore, IN). The FDA issued a Cleared decision on April 1, 2022, 37 days after receiving the submission on February 23, 2022. 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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