Cleared Traditional

K921278 - M-2000 DIAGNOSTIC AND TELERADIOLOGY WORKSTATION

K921278 is an FDA 510(k) clearance for M-2000 DIAGNOSTIC AND TELERADIOLOGY WOR..., manufactured by Metecon, Inc.. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K921278 · Metecon, Inc. · Radiology device
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May 1992
Decision
62d
Days
Class 1
Risk

K921278 is an FDA 510(k) clearance for the M-2000 DIAGNOSTIC AND TELERADIOLOGY WORKSTATION. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Metecon, Inc. (Menlo Park, US). The FDA issued a Cleared decision on May 18, 1992 after a review of 62 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 Metecon, Inc. devices

FDA 510(k) Submission Details - K921278

510(k) Number K921278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1992
Decision Date May 18, 1992
Days to Decision 62 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
45d faster than avg
Panel avg: 107d · This submission: 62d
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 80
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K921278.
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PHILIPS TELESCAN
K911773 · Philips Medical Systems, Inc. · Jun 1991
KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T
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