Compute-Rx-Comp (TM)

FDA 510(k) K910367 · Medicalibration Physics Consultant Services, Inc.

Substantially Equivalent

510(k) numberK910367

Submission

Device name
Compute-Rx-Comp (TM)
Applicant
Medicalibration Physics Consultant Services, Inc.
Ripon, CA, US
Received
January 29, 1991
Decision date
May 30, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KPQ – System, Simulation, Radiation Therapy
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5840
Specialty
Radiology

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Questions and answers

When was Compute-Rx-Comp (TM) cleared by the FDA?

Compute-Rx-Comp (TM) (K910367) received a 510(k) decision of Substantially Equivalent on May 30, 1991, 121 days after the submission was received.

What is the product code of K910367?

The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.