510(k) K201382
K201382 is an FDA 510(k) premarket notification submitted by De Gotzen S.R.L. for the device "X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)". The FDA issued a decision of Substantially Equivalent on Nov 18, 2020. The device falls under product code OAS (X-Ray, Tomography, Computed, Dental), a Class II device regulated under 21 CFR 892.1750. De Gotzen S.R.L. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 18, 2020
- Date Received
- May 26, 2020
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- X-Ray, Tomography, Computed, Dental
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type
- 510(k)
Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.