Cleared Special

K033637 - MEDICAL IMAGE DIGITIZER, MODEL 2908

K033637 is an FDA 510(k) clearance for MEDICAL IMAGE DIGITIZER, manufactured by Array Corp.. The device is a Class 2 Radiology device with product code LMA cleared through the Special 510(k) pathway after a 28-day FDA review.

K033637 · Array Corp. · Radiology device
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Dec 2003
Decision
28d
Days
Class 2
Risk

K033637 is an FDA 510(k) clearance for the MEDICAL IMAGE DIGITIZER, MODEL 2908. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Array Corp. (Shibuya-Ku, Tokyo, JP). The FDA issued a Cleared decision on December 17, 2003 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2030 - 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 - K033637

510(k) Number K033637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2003
Decision Date December 17, 2003
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

LMA Device Classification - Class 2, Special Controls

Product Code LMA Digitizer, Image, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2030
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 - LMA Digitizer, Image, Radiological

All 59
Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K033637.
MEDI-6000 MEDICAL IMAGE DIGITIZER
K091288 · Microtek International, Inc. · Aug 2009
FILM DIGITZER, MODEL 2908 MAMMO PRO
K063424 · Array Corp. · Dec 2006
NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER
K042484 · Nai Technology Products · Oct 2004
DIGITAL IMAGER
K032022 · Pyramid Medical, Inc. · Sep 2003
COBRASCAN CR-1 FILMLESS
K022810 · Radiographic Digital Imaging, Inc. · Oct 2002
FULCRUM
K021949 · Howtek, Inc. · Aug 2002
K033637 · MEDICAL IMAGE DIGITIZER, MODEL 2908
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