Affirm Breast Biopsy Guidance System

FDA 510(k) K122836 · Lorad, A Hologic Co.

Substantially Equivalent

510(k) numberK122836

Submission

Device name
Affirm Breast Biopsy Guidance System
Applicant
Lorad, A Hologic Co.
Danbury, CT, US
Received
September 17, 2012
Decision date
January 11, 2013
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

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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K191495Biopsy PositionerIZH · Special Fujifilm Corporation07/03/2019SE
K161575Affirm Lateral Arm Upright Biopsy AccessoryIZH · Traditional Hologic08/10/2016SE
K161920Comfort CoverIZH · Traditional Precision Dynamics Corporation07/15/2016SE
K153486Affirm Prone Biopsy SystemIZH · Traditional Hologic, Inc.04/01/2016SE
K152038MammoGRIPIZH · Traditional Women'S Imaging Solutions Enterprises, LLC12/22/2015SE
K123414Specboard Jr.IZH · Traditional Macbrud Corp., Medical Division01/11/2013SE
K113607Biopsy Digit S Biopsy SLIZH · Traditional Giotto USA, LLC08/10/2012SE
K113284Biopsy PositionerIZH · Traditional Fuji Film Medical Systems03/07/2012SE

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Questions and answers

When was Affirm Breast Biopsy Guidance System cleared by the FDA?

Affirm Breast Biopsy Guidance System (K122836) received a 510(k) decision of Substantially Equivalent on January 11, 2013, 116 days after the submission was received.

What is the product code of K122836?

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