Cleared Traditional

K973960 - MODEL 37-185

K973960 is an FDA 510(k) clearance for MODEL 37-185, manufactured by Victoreen, Inc.. The device is a Class 2 Radiology device with product code LHN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K973960 · Victoreen, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
90d
Days
Class 2
Risk

K973960 is an FDA 510(k) clearance for the MODEL 37-185. Classified as System, Radiation Therapy, Charged-particle, Medical (product code LHN), Class II - Special Controls.

Submitted by Victoreen, Inc. (Solon, US). The FDA issued a Cleared decision on January 14, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Victoreen, Inc. devices

FDA 510(k) Submission Details - K973960

510(k) Number K973960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1997
Decision Date January 14, 1998
Days to Decision 90 days
Submission Type Traditional
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
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHN Device Classification - Class 2, Special Controls

Product Code LHN System, Radiation Therapy, Charged-particle, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - LHN System, Radiation Therapy, Charged-particle, Medical

All 86
Devices cleared under the same product code (LHN) and FDA review panel - the closest regulatory comparables to K973960.
MOBETRON
K981112 · Intraop Medical, Inc. · Jul 1998
ARTOSCAN S
K981358 · Biosound Esaote, Inc. · Jul 1998
RADIO-PLAST
K981115 · Smith & Nephew, Inc. · Jun 1998
MULTIDOS, QC6PLUS
K972211 · Ptw-New York Corp. · Sep 1997
0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER
K972212 · Ptw-New York Corp. · Sep 1997
TREATMENT MANAGEMENT SYSTEM
K953391 · Siemens Medical Solutions USA, Inc. · Mar 1996