Cleared Traditional

K992385 - ORTHOPANTOMOGRAPH OP100D

K992385 is an FDA 510(k) clearance for ORTHOPANTOMOGRAPH OP100D, manufactured by Instrumentarium Corp.. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K992385 · Instrumentarium Corp. · Radiology device
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Sep 1999
Decision
74d
Days
Class 2
Risk

K992385 is an FDA 510(k) clearance for the ORTHOPANTOMOGRAPH OP100D. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Instrumentarium Corp. (Milwaukee, US). The FDA issued a Cleared decision on September 28, 1999 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 Instrumentarium Corp. devices

FDA 510(k) Submission Details - K992385

510(k) Number K992385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1999
Decision Date September 28, 1999
Days to Decision 74 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 107d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUH Device Classification - Class 2, Special Controls

Product Code MUH System, X-ray, Extraoral Source, Digital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - MUH System, X-ray, Extraoral Source, Digital

All 183
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