Cleared Traditional

K010391 - ATLAS MULTI-PURPOSE DSA SYSTEM

K010391 is an FDA 510(k) clearance for ATLAS MULTI-PURPOSE DSA SYSTEM, manufactured by Cares Built, Inc.. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K010391 · Cares Built, Inc. · Radiology device
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Mar 2001
Decision
31d
Days
Class 2
Risk

K010391 is an FDA 510(k) clearance for the ATLAS MULTI-PURPOSE DSA SYSTEM. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Cares Built, Inc. (Keyport, US). The FDA issued a Cleared decision on March 12, 2001 after a review of 31 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 Cares Built, Inc. devices

FDA 510(k) Submission Details - K010391

510(k) Number K010391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2001
Decision Date March 12, 2001
Days to Decision 31 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
76d faster than avg
Panel avg: 107d · This submission: 31d
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 149
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