Collimator, Bilaterial

FDA 510(k) K790168 · Cmsi

Substantially Equivalent

510(k) numberK790168

Submission

Device name
Collimator, Bilaterial
Applicant
Cmsi
Mchenry, IL, US
Received
January 23, 1979
Decision date
February 15, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KQA – Device, Beam Limiting, X-Ray, Therapeutic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5900
Specialty
Radiology

Other 510(k)s with product code KQA

510(k)DeviceApplicantDecision
K914784Papillion ProctoscopeKQA · Traditional Oldelft Corp. of America06/05/1992SE
K885126Philips RT250 Collimator (PK8050)KQA · Traditional Perkins Mfg. Co.06/01/1989SE
K844180The MCP-70-SE SystemKQA · Traditional Ellis Pharmaceutical Consulting, Inc.02/01/1985SE

More from Ellis Pharmaceutical Consulting, Inc.

510(k)DeviceDecision
K893499CMS Fast Cut, CMS Diamond and CMS Wire PassEQJ · Traditional 11/16/1989SE
K790169Tomographic ProgramsKPS · Traditional 02/15/1979SE

Questions and answers

When was Collimator, Bilaterial cleared by the FDA?

Collimator, Bilaterial (K790168) received a 510(k) decision of Substantially Equivalent on February 15, 1979, 23 days after the submission was received.

What is the product code of K790168?

The FDA product code is KQA – Device, Beam Limiting, X-Ray, Therapeutic, a Class II (moderate risk) device regulated under 21 CFR 892.5900.