Cleared Special

K001006 - THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE

K001006 is an FDA 510(k) clearance for THERATRON 780C/1000 WITH COMPUTERIZED C..., manufactured by Mds Nordion. The device is a Class 2 Radiology device with product code IWB cleared through the Special 510(k) pathway after a 29-day FDA review.

K001006 · Mds Nordion · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
29d
Days
Class 2
Risk

K001006 is an FDA 510(k) clearance for the THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE. Classified as System, Radiation Therapy, Radionuclide (product code IWB), Class II - Special Controls.

Submitted by Mds Nordion (Ottawa, CA). The FDA issued a Cleared decision on April 27, 2000 after a review of 29 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 - K001006

510(k) Number K001006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2000
Decision Date April 27, 2000
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
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 44
Devices cleared under the same product code (IWB) and FDA review panel - the closest regulatory comparables to K001006.
THERATRON EQUINOX, MODELS 80 CM AND 100 CM
K053485 · Mds Nordion, Inc. · Mar 2006
GAMMAPLAN
K051022 · Elekta Instrument AB · Jun 2005
MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM)
K041125 · Masep Med Science & Tech. Development (Shenzhen) C · Dec 2004
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1
K000478 · Accuray, Inc. · Apr 2000
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
K984563 · Accuray, Inc. · Jul 1999
LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001
K984328 · Elekta Instrument AB · May 1999
K001006 · THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE
Download PDF FDA Summary Mds Nordion