Cleared Traditional

K843920 - FLUOROSCAN/TM BY HEALTHMATE

K843920 is an FDA 510(k) clearance for FLUOROSCAN/TM BY HEALTHMATE, manufactured by Healthmate, Inc.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K843920 · Healthmate, Inc. · Radiology device
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Feb 1985
Decision
125d
Days
Class 2
Risk

K843920 is an FDA 510(k) clearance for the FLUOROSCAN/TM BY HEALTHMATE. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Healthmate, Inc. (Northbrook, US). The FDA issued a Cleared decision on February 7, 1985 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Healthmate, Inc. devices

FDA 510(k) Submission Details - K843920

510(k) Number K843920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1984
Decision Date February 07, 1985
Days to Decision 125 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 107d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAA System, X-ray, Fluoroscopic, Image-intensified

All 150
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K843920.
PET-SCOPE II IMAGE INTENSIFIER
K855213 · Philips Medical Systems (Cleveland), Inc. · Jan 1986
CANON X-RAY IMAGE DISTRIBUTOR
K853984 · Canon USA, Inc. · Oct 1985
EQUIPMENT SNAP KOVERS
K850959 · Advance Medical Designs, Inc. · Apr 1985
REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY
K840364 · Advanced Technology Laboratories, Inc. · Mar 1984
DIGITAL FLUOROGRAPHY X-RAY SYSTEM
K840191 · Adac Laboratories · Mar 1984
TECHNICARE MODEL 1047
K840390 · Technicare Corp. · Feb 1984