Fusion Flat Panel

FDA 510(k) K113449 · Icrco, Inc.

Substantially Equivalent

510(k) numberK113449

Submission

Device name
Fusion Flat Panel
Applicant
Icrco, Inc.
Torrance, CA, US
Received
November 21, 2011
Decision date
June 14, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1680
Specialty
Radiology

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Questions and answers

When was Fusion Flat Panel cleared by the FDA?

Fusion Flat Panel (K113449) received a 510(k) decision of Substantially Equivalent on June 14, 2012, 206 days after the submission was received.

What is the product code of K113449?

The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.