Biopsy Digit-Am

FDA 510(k) K062039 · Giotto USA, LLC

Substantially Equivalent

510(k) numberK062039

Submission

Device name
Biopsy Digit-Am
Applicant
Giotto USA, LLC
Carmel, IN, US
Received
July 19, 2006
Decision date
September 11, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 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

Other 510(k)s with product code IZH

510(k)DeviceApplicantDecision
K203509Smart FinderIZH · Special Ims Giotto S.P.A.07/14/2021SE
K202294Affirm Contrast BiopsyIZH · Special Hologic, Inc.10/05/2020SE
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
K122836Affirm Breast Biopsy Guidance SystemIZH · Special Lorad, A Hologic Co.01/11/2013SE
K113607Biopsy Digit S Biopsy SLIZH · Traditional Giotto USA, LLC08/10/2012SE

More from Giotto USA, LLC

510(k)DeviceDecision
K113607Biopsy Digit S Biopsy SLIZH · Traditional 08/10/2012SE
K111434Giotto Image 3D, Giotto Image 3D-LMUE · Traditional 10/27/2011SE

Questions and answers

When was Biopsy Digit-Am cleared by the FDA?

Biopsy Digit-Am (K062039) received a 510(k) decision of Substantially Equivalent on September 11, 2006, 54 days after the submission was received.

What is the product code of K062039?

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