# K082909: RSVP Half Sphere Phantom, Model DDP010

- Pathway: 510(k) (Traditional)
- Applicant: The Phantom Laboratory, Inc.
- Decided: Dec 23, 2008 after 84 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954634 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954634: Radiosurgery Verification Phantom, The Phantom Laboratory, Inc. (1995) Summary page 1.

## Indications for use
The RSVP Half Sphere Phantom TM is designed for verification of therapy dose delivery in radiation therapy machines, specifically the LeksellTM Gamma Knife sterotactic radiosurgery system. The phantom can also be used for periodic quality assurance evaluations and acceptance testing, and to perform reevaluations after equipment or software upgrades. The phantom works in conjunction with commercially available ion chambers, which are not manufactured by the Phantom Laboratory.

Source page: https://510kreport.com/device/K082909
Methodology: https://510kreport.com/methodology