Cleared Traditional

K872455 - DPS-4100 PLUS DIGITAL RADIOGRAPHY SYSTEM

K872455 is an FDA 510(k) clearance for DPS-4100 PLUS DIGITAL RADIOGRAPHY SYSTEM, manufactured by Adac Laboratories. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K872455 · Adac Laboratories · Radiology device
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Sep 1987
Decision
70d
Days
Class 2
Risk

K872455 is an FDA 510(k) clearance for the DPS-4100 PLUS DIGITAL RADIOGRAPHY SYSTEM. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Adac Laboratories (Milpitas, US). The FDA issued a Cleared decision on September 1, 1987 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

FDA 510(k) Submission Details - K872455

510(k) Number K872455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1987
Decision Date September 01, 1987
Days to Decision 70 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 107d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 2293
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K872455.
CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION
K880169 · Cemax, Inc. · Mar 1988
DAMON D.E.T.E.C.T IMAGE ENHANCER
K874865 · Damon Corp. · Dec 1987
DIGIVIEWER
K873646 · Digivision, Inc. · Oct 1987
POLYTRON MODELS 1001, 1002 AND 1004
K870821 · Siemens Medical Solutions USA, Inc. · Jul 1987
VIEW(TM) IMAGE PROCESSING AND VIEWING STATION
K864854 · Virtual Imaging · Feb 1987
PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)
K864519 · Parexel Intl. Corp. · Feb 1987
K872455 · DPS-4100 PLUS DIGITAL RADIOGRAPHY SYSTEM
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