Cleared Traditional

K921906 - HARRIS MODEL 2000

K921906 is an FDA 510(k) clearance for HARRIS MODEL 2000, manufactured by Harris Mfg. Co.. The device is a Class 2 Radiology device with product code LMC cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K921906 · Harris Mfg. Co. · Radiology device
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Nov 1992
Decision
195d
Days
Class 2
Risk

K921906 is an FDA 510(k) clearance for the HARRIS MODEL 2000. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Harris Mfg. Co. (Trenton, US). The FDA issued a Cleared decision on November 2, 1992 after a review of 195 days - an extended review cycle.

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 Harris Mfg. Co. devices

FDA 510(k) Submission Details - K921906

510(k) Number K921906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1992
Decision Date November 02, 1992
Days to Decision 195 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
88d slower than avg
Panel avg: 107d · This submission: 195d
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 76
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