Cleared Traditional

K943272 - VISUALIZER 2000

K943272 is an FDA 510(k) clearance for VISUALIZER 2000, manufactured by Vf-Works, Inc.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K943272 · Vf-Works, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
173d
Days
Class 2
Risk

K943272 is an FDA 510(k) clearance for the VISUALIZER 2000. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Vf-Works, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on December 27, 1994 after a review of 173 days - an extended review cycle.

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 Vf-Works, Inc. devices

FDA 510(k) Submission Details - K943272

510(k) Number K943272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1994
Decision Date December 27, 1994
Days to Decision 173 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 107d · This submission: 173d
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 192
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K943272.
SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES
K936236 · Shimadzu Medical Systems · May 1995
ARTHROGRAM TRAY
K950683 · Surgical Technologies, Inc. · May 1995
PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION
K945460 · Philips Medical Systems North America, Inc. · Mar 1995
NRF SYSTEM
K944973 · Philips Medical Systems (Cleveland), Inc. · Dec 1994
V-MAX OPTIONS
K943447 · Philips Medical Systems (Cleveland), Inc. · Nov 1994
PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD
K943805 · General Electric Co. · Sep 1994