Cleared Traditional

K971167 - NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES

K971167 is an FDA 510(k) clearance for NEOPROBE MODEL 1500 PORTABLE RADIOISOTO..., manufactured by Neoprobe Corp.. The device is a Class 1 Radiology device with product code IZD cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K971167 · Neoprobe Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
87d
Days
Class 1
Risk

K971167 is an FDA 510(k) clearance for the NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES. Classified as Probe, Uptake, Nuclear (product code IZD), Class I - General Controls.

Submitted by Neoprobe Corp. (Dublin, US). The FDA issued a Cleared decision on June 26, 1997 after a review of 87 days - a notably fast clearance cycle.

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: 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 Neoprobe Corp. devices

FDA 510(k) Submission Details - K971167

510(k) Number K971167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1997
Decision Date June 26, 1997
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
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

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