Icrco 3600M

FDA 510(k) K122510 · Icrco, Inc.

Substantially Equivalent

510(k) numberK122510

Submission

Device name
Icrco 3600M
Applicant
Icrco, Inc.
Torrance, CA, US
Received
August 17, 2012
Decision date
April 26, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MUE – Full Field Digital, System, X-Ray, Mammographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1715
Specialty
Radiology

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K254090I-View®MUE · Traditional Hologic, Inc.09/02/2026SE
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K254092Bellalun 2D (VDMS-1000S)MUE · Traditional Vieworks Co., Ltd.05/28/2026SE
K260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightMUE · Traditional GE Medical Systems SCS03/24/2026SE
K243420HestiaMUE · Traditional Genoray Co., Ltd.07/17/2025SE
K2438492430TCA with Xmaru WMUE · Special Rayence Co., Ltd.03/12/2025SE
K241113Vivix-MMUE · Traditional Vieworks Co., Ltd.01/16/2025SE
K233539MAMMOMAT B.brilliantMUE · Traditional Siemens Medical Solutions USA, Inc.03/27/2024SE
K220073RMF-2000MUE · Traditional DRTECH Corporation01/26/2023SE
K211720Planmed Clarity 2D, Planmed Clarify SMUE · Traditional Planmed OY07/18/2022SE

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Questions and answers

When was Icrco 3600M cleared by the FDA?

Icrco 3600M (K122510) received a 510(k) decision of Substantially Equivalent on April 26, 2013, 252 days after the submission was received.

What is the product code of K122510?

The FDA product code is MUE – Full Field Digital, System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1715.