Cleared Traditional

K100849 - SYNC-RX SYSTEM, MODEL AS00010

K100849 is an FDA 510(k) clearance for SYNC-RX SYSTEM, manufactured by Sync-Rx, Ltd.. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K100849 · Sync-Rx, Ltd. · Radiology device
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May 2010
Decision
56d
Days
Class 2
Risk

K100849 is an FDA 510(k) clearance for the SYNC-RX SYSTEM, MODEL AS00010. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Sync-Rx, Ltd. (Lakewood, US). The FDA issued a Cleared decision on May 21, 2010 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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 Sync-Rx, Ltd. devices

FDA 510(k) Submission Details - K100849

510(k) Number K100849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2010
Decision Date May 21, 2010
Days to Decision 56 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
51d faster than avg
Panel avg: 107d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZI Device Classification - Class 2, Special Controls

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 140
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