Linear Mc 150
by Carestream Health, Inc. 4 variants
Linear Mc 150 (1013309) is a medical device (FDA Class II; FDA product code IZX, Collimator, manual, radiographic) made by Carestream Health, Inc., cleared under FDA 510(k) K810598 on 10 Apr 1981 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 60889976567159), active as of 8 Jun 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number60889976567159 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK810598 | Date10 Apr 1981 | StatusActive |
Official records
- AccessGUDID record 60889976567159
- FDA 510(k) database K810598
Across registries
- FDA 510(k) K810598 decided 10 Apr 1981 Active
- FDA GUDID UDI-DI 60889976567159 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K810598
- Listed FDA GUDID 60889976567159
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Manual-aperture-control diagnostic x-ray system collimator, non-motorized
- Model / Ref / Catalog
- LINEAR MC 150, 1013309
- Primary DI / UDI-DI
- 60889976567159
- 510(k) Number
- FDA product code
- IZX
- GMDN term
- Manual-aperture-control diagnostic x-ray system collimator, non-motorized
- Device class
- Class II
- Regulation number
- 892.1610
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Manual-aperture-control diagnostic x-ray system collimator, non-motorized.