Cleared Traditional

K914808 - LEKSELL GAMMAPLAN (LGP)

K914808 is an FDA 510(k) clearance for LEKSELL GAMMAPLAN (LGP), manufactured by Elekta Instruments, Inc.. The device is a Class 2 Radiology device with product code IWB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K914808 · Elekta Instruments, Inc. · Radiology device
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Jan 1992
Decision
90d
Days
Class 2
Risk

K914808 is an FDA 510(k) clearance for the LEKSELL GAMMAPLAN (LGP). Classified as System, Radiation Therapy, Radionuclide (product code IWB), Class II - Special Controls.

Submitted by Elekta Instruments, Inc. (Tucker, US). The FDA issued a Cleared decision on January 23, 1992 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 892.5750 - 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 Elekta Instruments, Inc. devices

FDA 510(k) Submission Details - K914808

510(k) Number K914808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1991
Decision Date January 23, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
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.

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.