Stereotix

FDA 510(k) K873618 · Thomson-Cgr Medical Corp.

Substantially Equivalent

510(k) numberK873618

Submission

Device name
Stereotix
Applicant
Thomson-Cgr Medical Corp.
Columbia, MD, US
Received
September 8, 1987
Decision date
November 16, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IZH – System, X-Ray, Mammographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1710
Specialty
Radiology

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More from Giotto USA, LLC

510(k)DeviceDecision
K873544MPG-50 X-Ray GeneratorIZO · Traditional 10/26/1987SE
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Questions and answers

When was Stereotix cleared by the FDA?

Stereotix (K873618) received a 510(k) decision of Substantially Equivalent on November 16, 1987, 69 days after the submission was received.

What is the product code of K873618?

The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.