X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)
FDA 510(k) clearance K203374 · decided 2021-02-05
Clearance details
- K-number
- K203374
- Device name
- X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)
- Applicant
- De Götzen S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2020-11-16
- Decision date
- 2021-02-05
- Days to decision
- 81 days
- Clearance type
- Abbreviated
- Product code
- MUH
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Olgiate Olona, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.