Cleared Traditional

K961104 - NOTEBOOK IMAGER (FDA 510(k) Clearance)

Class I Radiology device.

K961104 · Digirad Corp. · Radiology device
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May 1997
Decision
434d
Days
Class 1
Risk

K961104 is an FDA 510(k) clearance for the NOTEBOOK IMAGER. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Digirad Corp. (Laurel, US). The FDA issued a Cleared decision on May 28, 1997 after a review of 434 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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: 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 Radiology submissions.

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Submission Details

510(k) Number K961104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1996
Decision Date May 28, 1997
Days to Decision 434 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
327d slower than avg
Panel avg: 107d · This submission: 434d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
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.