Cleared Traditional

K964485 - PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM

K964485 is an FDA 510(k) clearance for PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM, manufactured by Eliav , Ltd.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K964485 · Eliav , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
88d
Days
Class 2
Risk

K964485 is an FDA 510(k) clearance for the PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Eliav , Ltd. (Efrat, IL). The FDA issued a Cleared decision on February 4, 1997 after a review of 88 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 Eliav , Ltd. devices

FDA 510(k) Submission Details - K964485

510(k) Number K964485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1996
Decision Date February 04, 1997
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
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 386
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