# K163687: Olinda Exm

- Pathway: 510(k) (Traditional)
- Applicant: Hermes Medical Solutions AB
- Decided: Jul 19, 2017 after 203 days
- Product code: IYX (Camera, Scintillation (Gamma))
- Device class: 1
- Regulation: 21 CFR 892.1100
- 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 K033960 (2004). 1 ancestor in all.
56 later devices descend from it; 5 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033960: Olinda/Exm, Vanderbilt University (2004) Summary page 4.

## Most influential descendants
- K182624: MIM - MRT Dosimetry (2018), 53 descendants of its own
- K191928: AccuContour (2020), 30 descendants of its own
- K190379: MIM on Linux (2019), 14 descendants of its own
- K193562: AI-Rad Companion Organs RT (2020), 6 descendants of its own
- K193252: Contour ProtegeAI (2020), 6 descendants of its own

## Indications for use
The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application.

Source page: https://510kreport.com/device/K163687
Methodology: https://510kreport.com/methodology