Cleared Traditional

K932760 - DFS-2100

K932760 is an FDA 510(k) clearance for DFS-2100, manufactured by Dba Systems, Inc.. The device is a Class 2 Radiology device with product code LMA cleared through the Traditional 510(k) pathway after a 499-day FDA review.

K932760 · Dba Systems, Inc. · Radiology device
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Oct 1994
Decision
499d
Days
Class 2
Risk

K932760 is an FDA 510(k) clearance for the DFS-2100. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Dba Systems, Inc. (Melbourne, US). The FDA issued a Cleared decision on October 20, 1994 after a review of 499 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

FDA 510(k) Submission Details - K932760

510(k) Number K932760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1993
Decision Date October 20, 1994
Days to Decision 499 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
392d slower than avg
Panel avg: 107d · This submission: 499d
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 K932760.
LASERNET IMAGE MANAGER/PRINT SERVER
K952485 · Frantz Imaging, Inc. · Nov 1995
LUMISYS, LUMISCAN 20
K953964 · Lumisys, Inc. · Sep 1995
CEMAX SCANLINK V
K943357 · Cemax, Inc. · Nov 1994
AD/V A.5
K925799 · Adaptive Video, Inc. · Feb 1994
KONICA LD-4500 LASER DIGITIZER
K933830 · Konica Medical Corp. · Dec 1993
MEDSCAN 12
K933632 · Vidar Systems Corp. · Dec 1993
K932760 · DFS-2100
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