Cleared Traditional

K962615 - TUMORLOCALIZER MRI (FDA 510(k) Clearance)

K962615 · Ferguson Medical · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
624d
Days
-
Risk

K962615 is an FDA 510(k) clearance for the TUMORLOCALIZER MRI. Classified as Strip, Test Isoniazid (product code MIG).

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on March 19, 1998 after a review of 624 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

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Submission Details

510(k) Number K962615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1996
Decision Date March 19, 1998
Days to Decision 624 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
537d slower than avg
Panel avg: 87d · This submission: 624d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MIG Strip, Test Isoniazid
Device Class -