Cleared Traditional

PHOTOPHONE MULTIVIEW (K931186) - FDA 510(k) Clearance

Class I Radiology device.

K931186 · Image Data Corp. · Radiology device
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Nov 1993
Decision
258d
Days
Class 1
Risk

K931186 is an FDA 510(k) clearance for the PHOTOPHONE MULTIVIEW. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Image Data Corp. (San Antonio, US). The FDA issued a Cleared decision on November 22, 1993 after a review of 258 days - an extended review 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: 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.

View all Image Data Corp. devices

Submission Details

510(k) Number K931186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1993
Decision Date November 22, 1993
Days to Decision 258 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
151d slower than avg
Panel avg: 107d · This submission: 258d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 17
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K931186.
MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A
K952484 · Toshiba America Medical Systems, In.C · Jun 1995
KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS
K936116 · Eastman Kodak Company · Apr 1994
IMPAX 5000
K934386 · Heraeus Kulzer, Inc. · Jan 1994
IMPAX 1000
K933409 · Heraeus Kulzer, Inc. · Nov 1993
KODAK EKTASCAN IMAGELINK SYSTEM (KEIS)
K931551 · Eastman Kodak Company · Jun 1993
3M DIGITAL DISK INTERFACE UNIT
K920268 · 3M Company · May 1992