Cleared Special

MODIFICATION TO ARTOSCAN M (K010057) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K010057 · Biosound Esaote, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
25d
Days
Class 2
Risk

K010057 is an FDA 510(k) clearance for the MODIFICATION TO ARTOSCAN M. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Biosound Esaote, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 2, 2001 after a review of 25 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 Biosound Esaote, Inc. devices

Submission Details

510(k) Number K010057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2001
Decision Date February 02, 2001
Days to Decision 25 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
82d faster than avg
Panel avg: 107d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

All 475
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K010057.
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