Cleared Traditional

K896099 - DIGIGRAPH DIAGNOSTIC WORK/STATION (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896099 · Dolphin Imaging Systems · Radiology device
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Jan 1991
Decision
468d
Days
Class 2
Risk

K896099 is an FDA 510(k) clearance for the DIGIGRAPH DIAGNOSTIC WORK/STATION. Classified as Cephalometer (product code EAG), Class II - Special Controls.

Submitted by Dolphin Imaging Systems (Valencia, US). The FDA issued a Cleared decision on January 31, 1991 after a review of 468 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1830 - 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 K896099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1989
Decision Date January 31, 1991
Days to Decision 468 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
361d slower than avg
Panel avg: 107d · This submission: 468d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EAG Cephalometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1830
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.