# K090349: Clearvue Prone Breast Treatment Table

- Pathway: 510(k) (Traditional)
- Applicant: Orbital Therapy, LLC
- Decided: Mar 9, 2009 after 26 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Bionix RT-602.5 Prone Breast System: named in the summary without a submission number

## Most influential descendants
- K102765: Pronex (2010), 0 descendants of its own

## Recalls of this device
- Jan 7, 2016 · Class II · Z-1264-2016: Some of the Access ClearVue Prone Breast devices may contain scales that are misaligned from the zero reference with respect to other Access ClearVue Prone Breast devices. This can result in differenc

## Indications for use
ClearVue, a breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy systems. ClearVue is intended to be used to position and re- position patients for breast radiation therapy. ClearVue may be used with CT and MR scanners to acquire images for radiation therapy planning.

Source page: https://510kreport.com/device/K090349
Methodology: https://510kreport.com/methodology