Cleared Special

K100352 - DIAGNOSOFT HARP MODEL 2.06

K100352 is an FDA 510(k) clearance for DIAGNOSOFT HARP MODEL 2.06, manufactured by Diagnosoft, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Special 510(k) pathway after a 27-day FDA review.

K100352 · Diagnosoft, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
27d
Days
Class 2
Risk

K100352 is an FDA 510(k) clearance for the DIAGNOSOFT HARP MODEL 2.06. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Diagnosoft, Inc. (North Attleboro, US). The FDA issued a Cleared decision on March 11, 2010 after a review of 27 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.

FDA 510(k) Submission Details - K100352

510(k) Number K100352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2010
Decision Date March 11, 2010
Days to Decision 27 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
80d faster than avg
Panel avg: 107d · This submission: 27d
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.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

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K100352 · DIAGNOSOFT HARP MODEL 2.06
Download PDF FDA Summary Diagnosoft, Inc.