Cleared Special

K071193 - VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS

K071193 is an FDA 510(k) clearance for VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS, manufactured by Vidar Systems Corp.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 30-day FDA review.

K071193 · Vidar Systems Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
30d
Days
Class 2
Risk

K071193 is an FDA 510(k) clearance for the VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Vidar Systems Corp. (Deer Field, US). The FDA issued a Cleared decision on May 30, 2007 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K071193

510(k) Number K071193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2007
Decision Date May 30, 2007
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 423
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K071193.
CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)
K071682 · Alara, Inc. · Aug 2007
SATURN 9000
K063710 · New Medical Co., Ltd. · Jul 2007
DIRECT DIGITIZER, REGIUS MODEL 110
K071181 · Konica Minolta Medical & Graphic, Inc. · May 2007
SYNEPIX 4600 DETECTOR
K070829 · Analogic Corporation · May 2007
AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS
K071162 · Agfa Healthcare Corp. · May 2007
VIDAR VISION 2000
K070563 · Vidar Systems Corp. · Mar 2007
K071193 · VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS
Download PDF FDA Summary Vidar Systems Corp.