Cleared Traditional

K992112 - SAMSUNG RAYPAX FILM DIGITIZER

K992112 is an FDA 510(k) clearance for SAMSUNG RAYPAX FILM DIGITIZER, manufactured by Samsung Sds Co., Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K992112 · Samsung Sds Co., Ltd. · Radiology device
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Sep 1999
Decision
79d
Days
Class 2
Risk

K992112 is an FDA 510(k) clearance for the SAMSUNG RAYPAX FILM DIGITIZER. 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 Samsung Sds Co., Ltd. (Aubrey, US). The FDA issued a Cleared decision on September 9, 1999 after a review of 79 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.

View all Samsung Sds Co., Ltd. devices

FDA 510(k) Submission Details - K992112

510(k) Number K992112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1999
Decision Date September 09, 1999
Days to Decision 79 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
28d faster than avg
Panel avg: 107d · This submission: 79d
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 1512
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K992112.
ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP
K990241 · Accuimage Diagnostics Corp. · Sep 1999
SAMSUNG RAYPAX DISPLAY WORKSTATION
K992306 · Samsung Sds Co., Ltd. · Sep 1999
AX WORKSTATION
K992073 · Siemens Medical Solutions USA, Inc. · Sep 1999
ECHOCARDIOGRAPHY SYSTEM SERIES 95000
K992259 · Camtronics, Ltd. · Sep 1999
DIGITAL VIDEO RECORDING SYSTEM
K991738 · Kay Elemetrics Corp. · Aug 1999
GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C
K991629 · Ge Medical Systems, Inc. · Aug 1999