Cleared Traditional

K951581 - PINNACLE3 APEX

K951581 is an FDA 510(k) clearance for PINNACLE3 APEX, manufactured by Adac Laboratories. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 370-day FDA review.

K951581 · Adac Laboratories · Radiology device
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Apr 1996
Decision
370d
Days
Class 2
Risk

K951581 is an FDA 510(k) clearance for the PINNACLE3 APEX. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Adac Laboratories (Milpitas, US). The FDA issued a Cleared decision on April 8, 1996 after a review of 370 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Adac Laboratories devices

FDA 510(k) Submission Details - K951581

510(k) Number K951581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1995
Decision Date April 08, 1996
Days to Decision 370 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
263d slower than avg
Panel avg: 107d · This submission: 370d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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.

Regulatory Peers - IYE Accelerator, Linear, Medical

All 551
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