510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K002198Substantially Equivalent

Fluoroscan Profile, Model Tca 4 Plus; Fluoroscan Profile Iq, Model Tca 4R Plus

Fluoro Scan Imaging Systems, Inc., Northbrook IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002198 is the FDA 510(k) clearance record for FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS, a class II device, cleared for Fluoro Scan Imaging Systems, Inc. on under FDA product code OWB (Interventional Fluoroscopic X-Ray System). FDA's definition for product code OWB reads: "Interventional fluoroscopy". FDA records list one 510(k) clearance for Fluoro Scan Imaging Systems, Inc. As of , FDA records show no recalls naming K002198.

Clearance record

Decision date
Received
(89 days to decision)
Product code
OWB Interventional Fluoroscopic X-Ray System
Regulation
21 CFR 892.1650
Device class
Class II
Review panel
Radiology
Applicant
Fluoro Scan Imaging Systems, Inc. 650-B Anthony Trl., Northbrook IL
510(k) summary
Summary
Third party review
No

Clearances, product code OWB

Trailing 12 months
19 clearances under product code OWB in the twelve months to October 2026, April 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code OWB, trailing twelve months
MonthClearances
November 20251
December 20253
January 20261
February 20262
March 20262
April 20264
May 20261
June 20260
July 20262
August 20263
September 20260
October 20260