Cleared Traditional

K973441 - LEKSELL GAMMAPLAN

K973441 is an FDA 510(k) clearance for LEKSELL GAMMAPLAN, manufactured by Patterson Consulting Group, Inc.. The device is a Class 2 Radiology device with product code IWB cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K973441 · Patterson Consulting Group, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
202d
Days
Class 2
Risk

K973441 is an FDA 510(k) clearance for the LEKSELL GAMMAPLAN. Classified as System, Radiation Therapy, Radionuclide (product code IWB), Class II - Special Controls.

Submitted by Patterson Consulting Group, Inc. (San Diego, US). The FDA issued a Cleared decision on April 1, 1998 after a review of 202 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5750 - 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 Patterson Consulting Group, Inc. devices

FDA 510(k) Submission Details - K973441

510(k) Number K973441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1997
Decision Date April 01, 1998
Days to Decision 202 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
95d slower than avg
Panel avg: 107d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IWB Device Classification - Class 2, Special Controls

Product Code IWB System, Radiation Therapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5750
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 - IWB System, Radiation Therapy, Radionuclide

All 24
Devices cleared under the same product code (IWB) and FDA review panel - the closest regulatory comparables to K973441.
LEKSELL GAMMAPLAN
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GAMMAPLAN
K051022 · Elekta Instrument AB · Jun 2005
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K984328 · Elekta Instrument AB · May 1999
THERATRON 780E
K964606 · Theratronics, Inc. · Jun 1997
OUR ROTATING GAMMA SYSTEM
K970647 · Our Scientific Intl., Inc. · May 1997
DISPOSABLE SHADOW TRAY INSERTS
K871215 · Mick Radio-Nuclear Instruments, Inc. · Apr 1987