Cleared Special

K142997 - RTHawk

K142997 is an FDA 510(k) clearance for RTHawk, manufactured by Heartvista, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Special 510(k) pathway after a 68-day FDA review.

K142997 · Heartvista, Inc. · Radiology device
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Dec 2014
Decision
68d
Days
Class 2
Risk

K142997 is an FDA 510(k) clearance for the RTHawk, HeartVista Workstation with RTHawk. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Heartvista, Inc. (Menlo Park, US). The FDA issued a Cleared decision on December 17, 2014 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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 Heartvista, Inc. devices

FDA 510(k) Submission Details - K142997

510(k) Number K142997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2014
Decision Date December 17, 2014
Days to Decision 68 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 107d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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.

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