KQA — Device, Beam Limiting, X-Ray, Therapeutic Class II

FDA Device Classification

FDA product code KQA covers "Device, Beam Limiting, X-Ray, Therapeutic", a Class II medical device regulated under 21 CFR 892.5900. Submissions are reviewed by the Radiology panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
KQA
Device Class
Class II
Regulation Number
892.5900
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K914784oldelft corp. of americaPAPILLION PROCTOSCOPEJune 5, 1992
K885126perkins mfgPHILIPS RT250 COLLIMATOR (PK8050)June 1, 1989
K844180ellis pharmaceutical consultingTHE MCP-70-SE SYSTEMFebruary 1, 1985
K790168cmsiCOLLIMATOR, BILATERIALFebruary 15, 1979