Philips RT250 Collimator (PK8050)

FDA 510(k) K885126 · Perkins Mfg. Co.

Substantially Equivalent

510(k) numberK885126

Submission

Device name
Philips RT250 Collimator (PK8050)
Applicant
Perkins Mfg. Co.
Dallas, TX, US
Received
December 12, 1988
Decision date
June 1, 1989
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

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K790168Collimator, BilaterialKQA · Traditional Cmsi02/15/1979SE

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Questions and answers

When was Philips RT250 Collimator (PK8050) cleared by the FDA?

Philips RT250 Collimator (PK8050) (K885126) received a 510(k) decision of Substantially Equivalent on June 1, 1989, 171 days after the submission was received.

What is the product code of K885126?

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