ImagingRing System
510(k) K161400
ImagingRing System is a medical device (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by medPhoton GmbH, cleared under FDA 510(k) K161400 on 8 Dec 2016, 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 | NumberK161400 | Date8 Dec 2016 | StatusActive |
Official records
- FDA 510(k) database K161400
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K161400
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ImagingRing 1.1 | 1.1 | 19120075320013 | — | On the market |
| ImagingRing 1.2 | 1.2 | 19120075320037 | — | On the market |
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