Collimare CML-125-0001-C

by Collimare, LLC

Collimare CML-125-0001-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 00862005000313), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00862005000313 UDI-DI	Date28 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated	NumberK073124	Date16 Nov 2007Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00862005000313
FDA 510(k) database 510(k) number K073124

Across registries

2 registries list this device

FDA 510(k) K073124 decided 16 Nov 2007 Active
FDA GUDID UDI-DI 00862005000313 listed 28 Sep 2016 Listed

Timeline

2 dated events

16 Nov 2007 Cleared FDA 510(k) K073124
28 Sep 2016 Listed FDA GUDID 00862005000313

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Collimare
Generic name: Manual-aperture-control diagnostic x-ray system collimator, non-motorized
Model / reference: CML-125-0001-C

Primary DI / UDI-DI: 00862005000313
510(k) Number: K073124
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

Other devices from Collimare, LLC

See all devices from Collimare, LLC →

Properties

Single use
Serial number
Manufacturing date

Other properties (12, all answered No)