Cleared Traditional

K002608 - INVAC

K002608 is an FDA 510(k) clearance for INVAC, manufactured by Duncan Hynd Associates, Ltd.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K002608 · Duncan Hynd Associates, Ltd. · Radiology device
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Nov 2000
Decision
87d
Days
Class 2
Risk

K002608 is an FDA 510(k) clearance for the INVAC. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Duncan Hynd Associates, Ltd. (Teaneck, US). The FDA issued a Cleared decision on November 16, 2000 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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: 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 Duncan Hynd Associates, Ltd. devices

FDA 510(k) Submission Details - K002608

510(k) Number K002608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2000
Decision Date November 16, 2000
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
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 442
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