Submission Details
| 510(k) Number | K242591 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 30, 2024 |
| Decision Date | November 01, 2024 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
XERO-alpha
Nov 2024
Decision
63d
Days
Class 2
Risk
About This 510(k) Submission
K242591 is an FDA 510(k) clearance for the XERO-alpha, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by DRTECH Corporation (Jungwon-Gu, Seongnam-Si, KR). The FDA issued a Cleared decision on November 1, 2024, 63 days after receiving the submission on August 30, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.
Device Classification
| Product Code | EHD — Unit, X-ray, Extraoral With Timer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.1800 |
Manufacturer
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