Cleared Special

K071554 - VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM

K071554 is an FDA 510(k) clearance for VOLCANO S5/S5I INTRAVASCULAR IMAGING AN..., manufactured by Volcano Corporation. The device is a Class 2 Radiology device with product code OBJ cleared through the Special 510(k) pathway after a 211-day FDA review.

K071554 · Volcano Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
211d
Days
Class 2
Risk

K071554 is an FDA 510(k) clearance for the VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Volcano Corporation (Rancho Cordova,, US). The FDA issued a Cleared decision on January 4, 2008 after a review of 211 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.1200 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K071554

510(k) Number K071554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2007
Decision Date January 04, 2008
Days to Decision 211 days
Submission Type Special
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
104d slower than avg
Panel avg: 107d · This submission: 211d
Pathway characteristics
Modification to existing cleared device.

OBJ Device Classification - Class 2, Special Controls

Product Code OBJ Catheter, Ultrasound, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
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 - OBJ Catheter, Ultrasound, Intravascular

All 79
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K071554 · VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM
Download PDF FDA Summary Volcano Corporation