510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K113607Substantially Equivalent

Biopsy Digit S Biopsy Sl

Giotto USA, LLC, Rancho Santa Margarita CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113607 is the FDA 510(k) clearance record for BIOPSY DIGIT S BIOPSY SL, a class II device, cleared for Giotto USA, LLC on under FDA product code IZH (System, X-Ray, Mammographic). FDA records list 3 510(k) clearances for Giotto USA, LLC, from to . As of , FDA records show no recalls naming K113607.

Clearance record

Decision date
Received
(248 days to decision)
Product code
IZH System, X-Ray, Mammographic
Regulation
21 CFR 892.1710
Device class
Class II
Review panel
Radiology
Applicant
Giotto USA, LLC 81 Seacountry Ln., Rancho Santa Margarita CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IZH

Trailing 12 months

FDA records hold no clearances under product code IZH in the trailing twelve months.

FDA records show no clearances under product code IZH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IZH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260