510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153486Substantially Equivalent

Affirm Prone Biopsy System

Hologic, Inc., Danbury CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153486 is the FDA 510(k) clearance record for Affirm Prone Biopsy System, a class II device, cleared for Hologic, Inc. on under FDA product code IZH (System, X-Ray, Mammographic). FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show no recalls naming K153486.

Clearance record

Decision date
Received
(119 days to decision)
Product code
IZH System, X-Ray, Mammographic
Regulation
21 CFR 892.1710
Device class
Class II
Review panel
Radiology
Applicant
Hologic, Inc. 36 Apple Ridge Rd., Danbury CT
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