Cleared Traditional

K991537 - SAMSUNG RAYPAX SYSTEM

K991537 is an FDA 510(k) clearance for SAMSUNG RAYPAX SYSTEM, manufactured by Samsung Sds Co., Ltd.. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K991537 · Samsung Sds Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
64d
Days
Class 1
Risk

K991537 is an FDA 510(k) clearance for the SAMSUNG RAYPAX SYSTEM. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Samsung Sds Co., Ltd. (Aubrey, US). The FDA issued a Cleared decision on July 6, 1999 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2020 - 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 Samsung Sds Co., Ltd. devices

FDA 510(k) Submission Details - K991537

510(k) Number K991537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1999
Decision Date July 06, 1999
Days to Decision 64 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
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

LMD Device Classification - Class 1, General Controls

Product Code LMD System, Digital Image Communications, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.2020
Definition A Medical Image Communications Device Provides Electronic Transfer Of Medical Image Data Between Medical Devices. It May Include A Physical Communications Medium, Modems, Interfaces, And A Communications Protocol. It May Provide Simple Image Review Software Functionality For Medical Image Processing And Manipulation, Such As Grayscale Window And Level, Zoom And Pan, User Delineated Geometric Measurements, Compression, Or User Added Image Annotations. The Device Does Not Perform Advanced Image Processing Or Complex Quantitative Functions.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LMD System, Digital Image Communications, Radiological

All 79
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K991537.
STENTOR, PAGEVIEW
K992698 · Stentor, Inc. · Oct 1999
RAYPAX WEB CLINICAL SYSTEM
K992426 · Samsung Sds Co., Ltd. · Oct 1999
ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0
K992352 · Inteleradiology, Inc. · Sep 1999
STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM
K984000 · Surgical Navigation Technologies, Inc. · Jan 1999
IMAGEQUEST
K974707 · Visual Med, Inc. · Jul 1998
KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW
K981053 · Eastman Kodak Company · Jun 1998