510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K120388Substantially Equivalent

Insight - Fd 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)

K120388 is the FDA 510(k) clearance record for INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM, a class II device, cleared for Hologic, Inc. on under FDA product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile). FDA's definition for product code OXO reads: "Fluoroscopy of the human body". FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show no recalls naming K120388.

Clearance record

Decision date
Received
(59 days to decision)
Product code
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
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 OXO

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