Cleared Traditional

K951807 - KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER

K951807 is an FDA 510(k) clearance for KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, manufactured by Kodak Health Imaging Systems, Inc.. The device is a Class 2 Radiology device with product code LMC cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K951807 · Kodak Health Imaging Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
147d
Days
Class 2
Risk

K951807 is an FDA 510(k) clearance for the KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Kodak Health Imaging Systems, Inc. (Dallas, US). The FDA issued a Cleared decision on September 13, 1995 after a review of 147 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 Kodak Health Imaging Systems, Inc. devices

FDA 510(k) Submission Details - K951807

510(k) Number K951807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1995
Decision Date September 13, 1995
Days to Decision 147 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
40d slower than avg
Panel avg: 107d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LMC Device Classification - Class 2, Special Controls

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 84
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K951807.
ASPECT OPTICAM
K962051 · Aspect Electronics, Inc. · Aug 1996
ULTRA COMPACT VIDEO IMAGER
K953165 · International Imaging Electronics · May 1996
SIENET TELERADIOLOGY PRODUCT LINE
K955394 · Siemens Medical Solutions USA, Inc. · Feb 1996
FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L
K950721 · Fujifilm Medical System U.S.A., Inc. · May 1995
FIKO FO
K950610 · Fujifilm Medical System U.S.A., Inc. · Apr 1995
FUJI MEDICAL LASER IMAGER FL-IM D
K945475 · Fujifilm Medical System U.S.A., Inc. · Mar 1995