Cleared Traditional

K063424 - FILM DIGITZER, MODEL 2908 MAMMO PRO

K063424 is an FDA 510(k) clearance for FILM DIGITZER, manufactured by Array Corp.. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K063424 · Array Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
38d
Days
Class 2
Risk

K063424 is an FDA 510(k) clearance for the FILM DIGITZER, MODEL 2908 MAMMO PRO. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Array Corp. (Tokyo, JP). The FDA issued a Cleared decision on December 21, 2006 after a review of 38 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. 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 - K063424

510(k) Number K063424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2006
Decision Date December 21, 2006
Days to Decision 38 days
Submission Type Traditional
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
69d faster than avg
Panel avg: 107d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K063424.
TELERADPRO
K102476 · Vidar Systems Corp. · Oct 2010
VIDAR DENTAL FILM DIGITIZER
K093809 · Vidar Systems Corp. · Jan 2010
MEDI-6000 MEDICAL IMAGE DIGITIZER
K091288 · Microtek International, Inc. · Aug 2009
NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER
K042484 · Nai Technology Products · Oct 2004
MEDICAL IMAGE DIGITIZER, MODEL 2908
K033637 · Array Corp. · Dec 2003
DIGITAL IMAGER
K032022 · Pyramid Medical, Inc. · Sep 2003
K063424 · FILM DIGITZER, MODEL 2908 MAMMO PRO
Download PDF FDA Summary Array Corp.