TOMi Scope
FDA 510(k) clearance K191804 · decided 2019-12-05
Clearance details
- K-number
- K191804
- Device name
- TOMi Scope
- Applicant
- Photonicare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-07-05
- Decision date
- 2019-12-05
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- QJG
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Champaign, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OtoSight Middle Ear Scope (K222655) | Photonicare, Inc. | 2022-09-26 |
Recalls involving this device
No recalls on record reference this clearance.