# K033960: Olinda/Exm

- Pathway: 510(k) (Traditional)
- Applicant: Vanderbilt University
- Decided: Jun 15, 2004 after 176 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
No predicates in its family tree.
71 later devices descend from it; 3 cite it directly.
0 of 72 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) CDI3, Computer Program for Tissue Doses in Diagnostic Radiology: named in the summary without a submission number
- (no number) Camird: named in the summary without a submission number

## Most influential descendants
- K172218: MIM – Y90 Dosimetry (2017), 67 descendants of its own
- K163687: Olinda Exm (2017), 56 descendants of its own
- K180815: MIM - SPECTRA Quant (2018), 54 descendants of its own
- K182624: MIM - MRT Dosimetry (2018), 53 descendants of its own
- K191928: AccuContour (2020), 30 descendants of its own

## Indications for use
The purpose of Olinda BXM is to estimate the radiation dose received by internal organs as a result of administering a radiopharmaceutical.

Source page: https://510kreport.com/device/K033960
Methodology: https://510kreport.com/methodology