Cruxview
by CRUXELL Corp
510(k) K211317
Cruxview is a medical device (FDA Class II; FDA product code MUH, System, X-Ray, Extraoral Source, Digital) made by CRUXELL Corp, cleared under FDA 510(k) K211317 on 29 Jul 2021, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211317 | Date29 Jul 2021 | StatusActive |
Official records
- FDA 510(k) database K211317
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MUH
- FDA applicant
- Cruxell Corp.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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