Cleared Traditional

K873956 - ULTIMETER

K873956 is an FDA 510(k) clearance for ULTIMETER, manufactured by Radiation Measurements, Inc.. The device is a Class 1 Radiology device with product code LHO cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K873956 · Radiation Measurements, Inc. · Radiology device
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Oct 1987
Decision
32d
Days
Class 1
Risk

K873956 is an FDA 510(k) clearance for the ULTIMETER. Classified as Instrument, Quality-assurance, Radiologic (product code LHO), Class I - General Controls.

Submitted by Radiation Measurements, Inc. (Middleton, US). The FDA issued a Cleared decision on October 30, 1987 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1940 - 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 Radiation Measurements, Inc. devices

FDA 510(k) Submission Details - K873956

510(k) Number K873956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1987
Decision Date October 30, 1987
Days to Decision 32 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 107d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

LHO Device Classification - Class 1, General Controls

Product Code LHO Instrument, Quality-assurance, Radiologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1940
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 - LHO Instrument, Quality-assurance, Radiologic

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