Cleared Traditional

K072010 - QUANTUM DIREX SYSTEM

K072010 is an FDA 510(k) clearance for QUANTUM DIREX SYSTEM, manufactured by Quantum Medical Imaging, LLC. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K072010 · Quantum Medical Imaging, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
15d
Days
Class 2
Risk

K072010 is an FDA 510(k) clearance for the QUANTUM DIREX SYSTEM. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Quantum Medical Imaging, LLC (Ronkonkoma, US). The FDA issued a Cleared decision on August 7, 2007 after a review of 15 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K072010

510(k) Number K072010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2007
Decision Date August 07, 2007
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
JEFF D RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPR System, X-ray, Stationary

All 338
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K072010.
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
EOS
K071546 · Biospace Med · Sep 2007
PXS-810, PODIATRY X-RAY SYSTEM
K071392 · Source-Ray, Inc. · Aug 2007
X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM
K071401 · Imaging Dynamics Company , Ltd. · Jun 2007
SYNERAD OMNI, MODELS AN6255 AND AN6265
K071430 · Analogic Corp. · Jun 2007
K072010 · QUANTUM DIREX SYSTEM
Download PDF FDA Summary Quantum Medical Imagi…