Cleared Traditional

K974882 - DOWNSCAN LT

K974882 is an FDA 510(k) clearance for DOWNSCAN LT, manufactured by Merlin Engineering Works, Inc.. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K974882 · Merlin Engineering Works, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
143d
Days
Class 1
Risk

K974882 is an FDA 510(k) clearance for the DOWNSCAN LT. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Merlin Engineering Works, Inc. (Palo Alto, US). The FDA issued a Cleared decision on May 22, 1998 after a review of 143 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K974882

510(k) Number K974882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1997
Decision Date May 22, 1998
Days to Decision 143 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
36d slower than avg
Panel avg: 107d · This submission: 143d
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 129
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K974882.
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K974882 · DOWNSCAN LT
Download PDF FDA Summary Merlin Engineering Wo…