510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K132188Substantially Equivalent

Mammography Viewer Smv658

FUJIFILM Healthcare Americas Corporation, Stamford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132188 is the FDA 510(k) clearance record for MAMMOGRAPHY VIEWER SMV658, a class II device, cleared for Fujifilm Medical System U.S.A., Inc. on under FDA product code LLZ (System, Image Processing, Radiological). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K132188.

Clearance record

Decision date
Received
(102 days to decision)
Product code
LLZ System, Image Processing, Radiological
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Fujifilm Medical System U.S.A., Inc. 419 W. Ave., Stamford CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LLZ

Trailing 12 months
48 clearances under product code LLZ in the twelve months to October 2026, July 2026 the highest month at 8.
Show the numbers
Monthly 510(k) clearances under FDA product code LLZ, trailing twelve months
MonthClearances
November 20254
December 20251
January 20263
February 20264
March 20266
April 20262
May 20265
June 20265
July 20268
August 20263
September 20267
October 20260