Biopsy Digit S Biopsy SL

FDA 510(k) K113607 · Giotto USA, LLC

Substantially Equivalent

510(k) numberK113607

Submission

Device name
Biopsy Digit S Biopsy SL
Applicant
Giotto USA, LLC
Rancho Santa Margarita, CA, US
Received
December 6, 2011
Decision date
August 10, 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
IZH – System, X-Ray, Mammographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1710
Specialty
Radiology

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Questions and answers

When was Biopsy Digit S Biopsy SL cleared by the FDA?

Biopsy Digit S Biopsy SL (K113607) received a 510(k) decision of Substantially Equivalent on August 10, 2012, 248 days after the submission was received.

What is the product code of K113607?

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