# K191821: Blue Phantom PT

- Pathway: 510(k) (Abbreviated)
- Applicant: Iba Dosimetry GmbH
- Decided: Jan 23, 2020 after 199 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, 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: 2 generations back to K943199 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032594: One Dimensional Water Phantom, WP 1D, Wellhofer Dosimetrie (2003) Summary page 5.

## Indications for use
The intended use of Blue Phantom PT is to move detectors in one dimension within a water tank. It transfers indicated ionization beams (proton beams) at a certain position into electrical signals. Non-intended use of Blue Phantom PT The Blue Phantom PT is not meant for measurement orthogonal to the proton beam (inline and crossline measurements).

Source page: https://510kreport.com/device/K191821
Methodology: https://510kreport.com/methodology