Cleared Traditional

K964607 - THERATON 1000E

K964607 is an FDA 510(k) clearance for THERATON 1000E, manufactured by Theratronics, Inc.. The device is a Class 2 Radiology device with product code IWD cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K964607 · Theratronics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
191d
Days
Class 2
Risk

K964607 is an FDA 510(k) clearance for the THERATON 1000E. Classified as Device, Beam Limiting, Teletherapy, Radionuclide (product code IWD), Class II - Special Controls.

Submitted by Theratronics, Inc. (Kanata, Ontario, Canada, CA). The FDA issued a Cleared decision on May 28, 1997 after a review of 191 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 - K964607

510(k) Number K964607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1996
Decision Date May 28, 1997
Days to Decision 191 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
84d slower than avg
Panel avg: 107d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IWD Device Classification - Class 2, Special Controls

Product Code IWD Device, Beam Limiting, Teletherapy, 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.