DG 200/300 Digital Angiographic System

FDA 510(k) K852353 · Thomson-Cgr Medical Corp.

Substantially Equivalent

510(k) numberK852353

Submission

Device name
DG 200/300 Digital Angiographic System
Applicant
Thomson-Cgr Medical Corp.
Columbia, MD, US
Received
June 3, 1985
Decision date
August 7, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IXI – Block, Beam-Shaping, Radiation Therapy
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5710
Specialty
Radiology

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Questions and answers

When was DG 200/300 Digital Angiographic System cleared by the FDA?

DG 200/300 Digital Angiographic System (K852353) received a 510(k) decision of Substantially Equivalent on August 7, 1985, 65 days after the submission was received.

What is the product code of K852353?

The FDA product code is IXI – Block, Beam-Shaping, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5710.