510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132261Substantially Equivalent

Discovery Xr656 with Volumerad (Digital Tomosynthesis)

GE Healthcare, Waukesha WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132261 is the FDA 510(k) clearance record for DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS), a class II device, cleared for Ge Medical Systems, LLC on under FDA product code IZF (System, X-Ray, Tomographic). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show one recall naming K132261.

Clearance record

Decision date
Received
(122 days to decision)
Product code
IZF System, X-Ray, Tomographic
Regulation
21 CFR 892.1740
Device class
Class II
Review panel
Radiology
Applicant
Ge Medical Systems, LLC 3000 N. Grandview Blvd., Waukesha WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IZF

Trailing 12 months
2 clearances under product code IZF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IZF, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260