Gammamed 12IT High Dose Rate Remote Afterloader

FDA 510(k) K912555 · Rts Technology, Inc.

Substantially Equivalent

510(k) numberK912555

Submission

Device name
Gammamed 12IT High Dose Rate Remote Afterloader
Applicant
Rts Technology, Inc.
North Andover, MA, US
Received
June 11, 1991
Decision date
August 2, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JAQ – System, Applicator, Radionuclide, Remote-Controlled
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5700
Specialty
Radiology

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Questions and answers

When was Gammamed 12IT High Dose Rate Remote Afterloader cleared by the FDA?

Gammamed 12IT High Dose Rate Remote Afterloader (K912555) received a 510(k) decision of Substantially Equivalent on August 2, 1991, 52 days after the submission was received.

What is the product code of K912555?

The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.