# K983678: Elekta Oncology Systems Precise Treatment Table

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instruments, Inc.
- Decided: Jan 15, 1999 after 87 days
- Product code: JAI (Couch, Radiation Therapy, Powered)
- Device class: 2
- Regulation: 21 CFR 892.5770
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Eos Ram: named in the summary without a submission number
- (no number) Pedestal: named in the summary without a submission number

## Most influential descendants
- K060870: Avanza (2006), 0 descendants of its own
- K032248: Precise Carbon Fiber Table Top, Model 11-999 (2003), 0 descendants of its own

## Recalls of this device
- Jan 29, 2015 · Class II · Z-1238-2015: It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenance. Clinical
- Mar 14, 2013 · Class II · Z-1072-2013: The Column rotation can accidentally be moved to a different position which in the locked position.
- Mar 10, 2008 · Not classified · Z-1030-2011: Possible error in the table longitudinal position.
- Jan 11, 2007 · Not classified · Z-1432-2010: In some instances, the bolts which are supplied with the table have sheared off, resulting in inability to operate the powered table.

## Indications for use
The Precise™ Treatment Table is intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. It is for use with existing Elekta Linear Accelerators and Simulators and adaptable to third party radiotherapy products.

Source page: https://510kreport.com/device/K983678
Methodology: https://510kreport.com/methodology