Dynamic Shielding Radiation Table

FDA 510(k) K982446 · American Biophysics, Inc.

Substantially Equivalent

510(k) numberK982446

Submission

Device name
Dynamic Shielding Radiation Table
Applicant
American Biophysics, Inc.
Mccordsville, IN, US
Received
July 15, 1998
Decision date
September 29, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAI – Couch, Radiation Therapy, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5770
Specialty
Radiology

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Questions and answers

When was Dynamic Shielding Radiation Table cleared by the FDA?

Dynamic Shielding Radiation Table (K982446) received a 510(k) decision of Substantially Equivalent on September 29, 1998, 76 days after the submission was received.

What is the product code of K982446?

The FDA product code is JAI – Couch, Radiation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.5770.