Collimare CTL-150-0001-C
Collimare CTL-150-0001-C is a medical device (FDA Class II; FDA product code IZX, Collimator, Manual, Radiographic) made by Collimare, LLC, cleared under FDA 510(k) K073124 on 16 Nov 2007 and listed in FDA GUDID since 28 Sep 2016 (UDI-DI 00862005000368), 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 | GUDID listing | Number00862005000368 | Date28 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK073124 | Date16 Nov 2007 | StatusActive |
Official records
- AccessGUDID record 00862005000368
- FDA 510(k) database K073124
Across registries
- FDA 510(k) K073124 decided 16 Nov 2007 Active
- FDA GUDID UDI-DI 00862005000368 listed 28 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K073124
- Listed FDA GUDID 00862005000368
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Collimare
- Generic name
- Manual-aperture-control diagnostic x-ray system collimator, motorized
- Model / reference
- CTL-150-0001-C
- Primary DI / UDI-DI
- 00862005000368
- 510(k) Number
- FDA product code
- IZX
- GMDN term
- Manual-aperture-control diagnostic x-ray system collimator, motorized
- Device class
- Class II
- Regulation number
- 892.1610
- GUDID distribution status
- In Commercial Distribution
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