Cleared Traditional

K931022 - ARTOSCAN

K931022 is an FDA 510(k) clearance for ARTOSCAN, manufactured by Biosound, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K931022 · Biosound, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
220d
Days
Class 2
Risk

K931022 is an FDA 510(k) clearance for the ARTOSCAN. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on October 7, 1993 after a review of 220 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosound, Inc. devices

FDA 510(k) Submission Details - K931022

510(k) Number K931022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1993
Decision Date October 07, 1993
Days to Decision 220 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 107d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K931022.
MRT-150A MRI SYSTEM W/SUPER PERFORMANCE PACKAGE
K925286 · Toshiba America Mri, Inc. · Oct 1993
GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0
K925985 · Elscint, Inc. · Oct 1993
MRINNERVU DISPOSABLE ENDORECTAL CERVIX COIL#BCR-15
K930779 · Medrad, Inc. · Oct 1993
EDGE SYSTEM
K932693 · Philips Medical Systems (Cleveland), Inc. · Oct 1993
MRINNERVU DISPOSABLE ENDORECTAL COLON COIL,#PCC-15
K930544 · Medrad, Inc. · Sep 1993
MODEL 640GE-64: QUADRATURE PELVIC COIL
K930674 · Medical Advances, Inc. · Sep 1993