Cleared Special

K090972 - LEKSELL GAMMAPLAN

K090972 is the FDA 510(k) clearance for LEKSELL GAMMAPLAN by Elekta Instrument AB. It is a Class 2 Radiology device (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)
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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.

View all Elekta Instrument AB devices

Submission Details

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.

Device Classification

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 127
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K090972.
LEKSELL GAMMAPLAN
K103093 · Elekta Instrument AB · Dec 2010
ECLIPSE TREATMENT PLANNING SYSTEM
K102011 · Varian Medical Systems, Inc. · Sep 2010
SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864
K101119 · Siemens Medical Solutions USA, Inc. · Jun 2010
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
K091492 · Varian Medical Systems, Inc. · Jun 2009
PINNACLE3 SMARTARC
K090808 · Philips Medical Systems, Inc. · Apr 2009
MODEIFICATION TO IPLAN RT DOSE
K080888 · Brainlab AG · Jun 2008