Cleared Special

K062390 - CRYSTALVIEW R200

K062390 is an FDA 510(k) clearance for CRYSTALVIEW R200, manufactured by Alara, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 33-day FDA review.

K062390 · Alara, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
33d
Days
Class 2
Risk

K062390 is an FDA 510(k) clearance for the CRYSTALVIEW R200. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Alara, Inc. (Fremont, US). The FDA issued a Cleared decision on September 18, 2006 after a review of 33 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 - K062390

510(k) Number K062390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2006
Decision Date September 18, 2006
Days to Decision 33 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
74d faster than avg
Panel avg: 107d · This submission: 33d
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 K062390.
DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI
K062376 · Rf Systems Lab. · Oct 2006
CR 85-X
K062742 · Agfa Corporation · Oct 2006
XPLORER 1600 PLUS
K062586 · Imaging Dynamics Company , Ltd. · Sep 2006
AGFA MODEL CR30-X
K062223 · Agfa Corporation · Sep 2006
CXDI-40EC
K062221 · Canon, Inc. · Aug 2006
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200
K061538 · Alara, Inc. · Jun 2006
K062390 · CRYSTALVIEW R200
Download PDF FDA Summary Alara, Inc.