Cleared Traditional

K961321 - GAMMA GUIDANCE SYSTEM

K961321 is an FDA 510(k) clearance for GAMMA GUIDANCE SYSTEM, manufactured by Radiation Monitoring Devices, Inc.. The device is a Class 1 Radiology device with product code IZD cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K961321 · Radiation Monitoring Devices, Inc. · Radiology device
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Feb 1997
Decision
311d
Days
Class 1
Risk

K961321 is an FDA 510(k) clearance for the GAMMA GUIDANCE SYSTEM. Classified as Probe, Uptake, Nuclear (product code IZD), Class I - General Controls.

Submitted by Radiation Monitoring Devices, Inc. (Watertown, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1320 - 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. Elevated predicate reliance profile. 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 Radiation Monitoring Devices, Inc. devices

FDA 510(k) Submission Details - K961321

510(k) Number K961321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1996
Decision Date February 10, 1997
Days to Decision 311 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
204d slower than avg
Panel avg: 107d · This submission: 311d
Pathway characteristics
Predicate-based equivalence.

IZD Device Classification - Class 1, General Controls

Product Code IZD Probe, Uptake, Nuclear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1320
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 - IZD Probe, Uptake, Nuclear

Devices cleared under the same product code (IZD) and FDA review panel - the closest regulatory comparables to K961321.
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