# K001006: Theratron 780C/1000 with Computerized Console Upgrade

- Pathway: 510(k) (Special)
- Applicant: Mds Nordion
- Decided: Apr 27, 2000 after 29 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jul 8, 2004 · Not classified · Z-1180-06: The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions.
- Jul 8, 2004 · Not classified · Z-1178-06: The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions.

Source page: https://510kreport.com/device/K001006
Methodology: https://510kreport.com/methodology