Cleared Special

K073114 - IMIX INSIGHT X-RAY SYSTEMS

K073114 is an FDA 510(k) clearance for IMIX INSIGHT X-RAY SYSTEMS, manufactured by Imix Adr Finland OY. The device is a Class 2 Radiology device with product code KPR cleared through the Special 510(k) pathway after a 73-day FDA review.

K073114 · Imix Adr Finland OY · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
73d
Days
Class 2
Risk

K073114 is an FDA 510(k) clearance for the IMIX INSIGHT X-RAY SYSTEMS. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Imix Adr Finland OY (Deer Field, US). The FDA issued a Cleared decision on January 17, 2008 after a review of 73 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 - K073114

510(k) Number K073114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2007
Decision Date January 17, 2008
Days to Decision 73 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
34d faster than avg
Panel avg: 107d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
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 - KPR System, X-ray, Stationary

All 321
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K073114.
CHRYSALIS
K080655 · Meta Imaging Solutions, LLC · May 2008
DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16
K080553 · Vieworks Co., Ltd. · Apr 2008
FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371
K073650 · Fujifilm Medical Systems U.S.A, Inc. · Feb 2008
INTUITION, MODEL 0170
K073632 · Arcoma AB · Jan 2008
IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K
K072867 · Imix Adr Finland OY · Nov 2007
RAD VISION, MODELS E AND EU
K072659 · Almana Medical Imaging · Nov 2007
K073114 · IMIX INSIGHT X-RAY SYSTEMS
Download PDF FDA Summary Imix Adr Finland OY