Cleared Traditional

Leksell GammaPlan (K173791) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173791 · Elekta Instrument AB · Radiology device
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Optimized for regulatory review, auditing and printing
Feb 2018
Decision
57d
Days
Class 2
Risk

K173791 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 Elekta Instrument AB (Stockholm, SE). The FDA issued a Cleared decision on February 9, 2018 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Elekta Instrument AB devices

Submission Details

510(k) Number K173791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2017
Decision Date February 09, 2018
Days to Decision 57 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
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 47
Devices cleared under the same product code (IWB) and FDA review panel - the closest regulatory comparables to K173791.
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