Cleared Traditional

K964606 - THERATRON 780E

K964606 is an FDA 510(k) clearance for THERATRON 780E, manufactured by Theratronics, Inc.. The device is a Class 2 Radiology device with product code IWB cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K964606 · Theratronics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
220d
Days
Class 2
Risk

K964606 is an FDA 510(k) clearance for the THERATRON 780E. 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 June 26, 1997 after a review of 220 days - an extended review 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: 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 Theratronics, Inc. devices

FDA 510(k) Submission Details - K964606

510(k) Number K964606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1996
Decision Date June 26, 1997
Days to Decision 220 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
113d slower than avg
Panel avg: 107d · This submission: 220d
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.

Regulatory Peers - IWB System, Radiation Therapy, Radionuclide

All 24
Devices cleared under the same product code (IWB) and FDA review panel - the closest regulatory comparables to K964606.
GAMMAPLAN
K051022 · Elekta Instrument AB · Jun 2005
LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001
K984328 · Elekta Instrument AB · May 1999
LEKSELL GAMMAPLAN
K973441 · Patterson Consulting Group, Inc. · Apr 1998
OUR ROTATING GAMMA SYSTEM
K970647 · Our Scientific Intl., Inc. · May 1997
DISPOSABLE SHADOW TRAY INSERTS
K871215 · Mick Radio-Nuclear Instruments, Inc. · Apr 1987