Cleared Traditional

MINI IMAGER (K950423) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950423 · Regulatory Management Services · Radiology device
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Optimized for regulatory review, auditing and printing
May 1995
Decision
99d
Days
Class 2
Risk

K950423 is an FDA 510(k) clearance for the MINI IMAGER. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Regulatory Management Services (San Leandro, US). The FDA issued a Cleared decision on May 12, 1995 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2040 - 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 Regulatory Management Services devices

Submission Details

510(k) Number K950423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1995
Decision Date May 12, 1995
Days to Decision 99 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 107d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LMC Camera, Multi Format, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LMC Camera, Multi Format, Radiological

All 17
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K950423.
KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600
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SIENET TELERADIOLOGY PRODUCT LINE
K955394 · Siemens Medical Solutions USA, Inc. · Feb 1996
KODAK EKTASCAN, XLT7720, XLT7700, PCD 2000
K922411 · Eastman Kodak Company · Aug 1992
KODAK EKTASCAN 2180 LASER PRINTER
K921743 · Eastman Kodak Company · Jul 1992
KODAK EKTASCAN 1120 LASER PRINTER
K914582 · Eastman Kodak Company · Dec 1991