Cleared Traditional

K970652 - MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE

K970652 is an FDA 510(k) clearance for MITRA IMAGING, manufactured by Mitra Imaging, Inc.. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K970652 · Mitra Imaging, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
70d
Days
Class 1
Risk

K970652 is an FDA 510(k) clearance for the MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Mitra Imaging, Inc. (Waterloo, Ontario, CA). The FDA issued a Cleared decision on May 2, 1997 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2020 - 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 Mitra Imaging, Inc. devices

FDA 510(k) Submission Details - K970652

510(k) Number K970652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1997
Decision Date May 02, 1997
Days to Decision 70 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
37d faster than avg
Panel avg: 107d · This submission: 70d
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 45
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K970652.
MULTIPICS(ME-977)
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RIS SCANVIEW SYSTEM (RSVS)
K970641 · Radiology Information Systems, Inc. · May 1997
FREEPIX/PIXPACS DICOM/HTTP GATEWAY
K970174 · Pixelinks, Inc. · May 1997
FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
K970293 · Fujifilm Medical System U.S.A., Inc. · Mar 1997
AMICAS WEB/INTRANET IMAGE SERVER
K970064 · Autocyt Group, Inc. · Mar 1997