510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K051025Substantially Equivalent

Fluoroscan Insight Mini C-Arm Fluoroscopic Imaging System

Hologic, Inc., Bedford MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051025 is the FDA 510(k) clearance record for FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM, a class II device, cleared for Hologic, Inc. on under FDA product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified). FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show 4 recalls naming K051025.

Clearance record

Decision date
Received
(21 days to decision)
Product code
JAA System, X-Ray, Fluoroscopic, Image-Intensified
Regulation
21 CFR 892.1650
Device class
Class II
Review panel
Radiology
Applicant
Hologic, Inc. 35 Crosby Dr., Bedford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JAA

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