Catalyst

FDA 510(k) K113276 · C-Rad Positioning AB

Substantially Equivalent

510(k) numberK113276

Submission

Device name
Catalyst
Applicant
C-Rad Positioning AB
Uppsala, SE
Received
November 7, 2011
Decision date
February 27, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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 Catalyst cleared by the FDA?

Catalyst (K113276) received a 510(k) decision of Substantially Equivalent on February 27, 2012, 112 days after the submission was received.

What is the product code of K113276?

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