Cleared Special

K090972 - LEKSELL GAMMAPLAN

K090972 is an FDA 510(k) clearance for LEKSELL GAMMAPLAN, manufactured by Elekta Instrument AB. The device is a Class 2 Radiology device with product code MUJ cleared through the Special 510(k) pathway after a 105-day FDA review.

K090972 · Elekta Instrument AB · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
105d
Days
Class 2
Risk

K090972 is an FDA 510(k) clearance for the LEKSELL GAMMAPLAN. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Elekta Instrument AB (Stockholm, SE). The FDA issued a Cleared decision on July 20, 2009 after a review of 105 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K090972

510(k) Number K090972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2009
Decision Date July 20, 2009
Days to Decision 105 days
Submission Type Special
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
2d faster than avg
Panel avg: 107d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
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 - MUJ System, Planning, Radiation Therapy Treatment

All 257
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K090972.
SIMUPLAN TREATMENT PLANNING SYSTEM
K093391 · Simuplan S.L. · Dec 2009
DOSE VOLUME HISTOGRAM (DVH) EVALUATOR
K092928 · Diversilabs, LLC · Dec 2009
XIO RTP SYSTEM
K092132 · Computerized Medical Systems, Inc. · Sep 2009
MONACO RTP SYSTEM, VMAT OPTION
K091179 · Computerized Medical Systems, Inc. · Jul 2009
TIGRT TPS
K090893 · Linatech, LLC · Jul 2009
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
K091492 · Varian Medical Systems, Inc. · Jun 2009
K090972 · LEKSELL GAMMAPLAN
Download PDF FDA Summary Elekta Instrument AB