Cleared Traditional

K090672 - AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH ...

K090672 is an FDA 510(k) clearance for AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH ..., manufactured by Agfa Healthcare N.V.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K090672 · Agfa Healthcare N.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
66d
Days
Class 2
Risk

K090672 is an FDA 510(k) clearance for the AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Agfa Healthcare N.V. (Mortsel, BE). The FDA issued a Cleared decision on May 18, 2009 after a review of 66 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.

View all Agfa Healthcare N.V. devices

FDA 510(k) Submission Details - K090672

510(k) Number K090672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2009
Decision Date May 18, 2009
Days to Decision 66 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
41d faster than avg
Panel avg: 107d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 244
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K090672.
DIGITAL RADIOGRAPHY CXDI-60C
K091545 · Canon, Inc. · Jun 2009
DIGITAL RADIOGRAPHY MODEL CXDI-55G
K091435 · Canon, Inc. · May 2009
DIGITAL RADIOGRAPHY, MODEL CXDI-55C
K091436 · Canon, Inc. · May 2009
CARESTREAM DRX-1 SYSTEM
K090318 · Carestream Health, Inc. · Apr 2009
DIGITAL RADIOGRAPHY CXDI-40G COMPACT
K090623 · Canon USA, Inc. · Mar 2009
DRAD3000E/RADREX-I
K082494 · Toshiba America Medical Systems, In.C · Sep 2008