Theraview

FDA 510(k) K960510 · Infimed, Inc.

Substantially Equivalent

510(k) numberK960510

Submission

Device name
Theraview
Applicant
Infimed, Inc.
Liverpool, NY, US
Received
February 5, 1996
Decision date
April 22, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

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Questions and answers

When was Theraview cleared by the FDA?

Theraview (K960510) received a 510(k) decision of Substantially Equivalent on April 22, 1996, 77 days after the submission was received.

What is the product code of K960510?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.