Cleared Traditional

K982785 - FILM DIGITIZER MODEL 2905

K982785 is an FDA 510(k) clearance for FILM DIGITIZER MODEL 2905, 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 69-day FDA review.

K982785 · Array Corp. · Radiology device
Download Printable Device Report (PDF)
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Oct 1998
Decision
69d
Days
Class 2
Risk

K982785 is an FDA 510(k) clearance for the FILM DIGITIZER MODEL 2905. 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 October 15, 1998 after a review of 69 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.

View all Array Corp. devices

FDA 510(k) Submission Details - K982785

510(k) Number K982785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1998
Decision Date October 15, 1998
Days to Decision 69 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
38d faster than avg
Panel avg: 107d · This submission: 69d
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 14
Devices cleared under the same product code (LMA) and FDA review panel - the closest regulatory comparables to K982785.
CCD CAMERA, MODEL 9000
K990066 · Camtronics, Ltd. · Mar 1999
KONICA DIRECT DIGITIZER REGIUS MODEL 330
K980873 · Konica Corp. · Jun 1998
LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER
K980809 · Lumisys, Inc. · May 1998
VIDAR VXR LS LASER FILM DIGITIZER
K974315 · Vidar Systems Corp. · Apr 1998
LD2000 SERIES
K980565 · General Scanning, Inc. · Mar 1998
DI-2000
K980213 · Lumisys, Inc. · Mar 1998