Cleared Special

K071204 - SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6

K071204 is an FDA 510(k) clearance for SITE-RITE 6 ULTRASOUND SYSTEM, manufactured by C.R. Bard, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Special 510(k) pathway after a 17-day FDA review.

K071204 · C.R. Bard, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
17d
Days
Class 2
Risk

K071204 is an FDA 510(k) clearance for the SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 18, 2007 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K071204

510(k) Number K071204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2007
Decision Date May 18, 2007
Days to Decision 17 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
90d faster than avg
Panel avg: 107d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

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