Cleared Special

K983917 - THERATRON ELITE

K983917 is an FDA 510(k) clearance for THERATRON ELITE, manufactured by Theratronics, Inc.. The device is a Class 2 Radiology device with product code IWB cleared through the Special 510(k) pathway after a 30-day FDA review.

K983917 · Theratronics, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
30d
Days
Class 2
Risk

K983917 is an FDA 510(k) clearance for the THERATRON ELITE. Classified as System, Radiation Therapy, Radionuclide (product code IWB), Class II - Special Controls.

Submitted by Theratronics, Inc. (Kanata, Ontario, Canada, CA). The FDA issued a Cleared decision on December 4, 1998 after a review of 30 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. 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. Low regulatory complexity profile. 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 - K983917

510(k) Number K983917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1998
Decision Date December 04, 1998
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 41
Devices cleared under the same product code (IWB) and FDA review panel - the closest regulatory comparables to K983917.
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1
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K964606 · Theratronics, Inc. · Jun 1997
OUR ROTATING GAMMA SYSTEM
K970647 · Our Scientific Intl., Inc. · May 1997
K983917 · THERATRON ELITE
Download PDF FDA Summary Theratronics, Inc.