510(k) · Cleared
ClearedOlinda/Exm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vanderbilt University · IYX Camera, Scintillation (Gamma)
Cleared on Jun 15, 2004 after a 176-day review. The FDA summary names its predicate without a number. 71 later devices descend from it.
- Decided
- Jun 15, 2004
- Review
- 176 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 0
71 later devices descend from it, 3 citing it directly.
- This deviceK033960 Olinda/ExmVanderbilt University · 2004
- Descendant · cites it directly · 67 of its ownK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- Descendant · cites it directly · 56 of its ownK163687 Olinda ExmHermes Medical Solutions AB · 2017
- Descendant · 2 generations on · 54 of its ownK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- Descendant · 2 generations on · 53 of its ownK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- Descendant · 3 generations on · 30 of its ownK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K172218MIM – Y90 DosimetryMim Software, Inc. · 2017 · cites it directly67descendants
- K163687Olinda ExmHermes Medical Solutions AB · 2017 · cites it directly56descendants
- K180815MIM - SPECTRA QuantMim Software, Inc. · 2018 · 2 generations on54descendants
- K182624MIM - MRT DosimetryMim Software, Inc. · 2018 · 2 generations on53descendants
- K191928AccuContourXiamen Manteia Technology, Ltd. · 2020 · 3 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033960 | Olinda/Exm | Vanderbilt University | 2004 | — |
| +1 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| +1 | K163687 | Olinda Exm | Hermes Medical Solutions AB | 2017 | — |
| +2 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| +2 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| +3 | K191928 | AccuContour | Xiamen Manteia Technology, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 9 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 8 | 0 |
| 2025 | 11 | 0 |
| 2026 | 11 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYX device
- #1 K230221 QDOSE® Multi-purpose Voxel Dosimetry…score 6.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | CDI3, Computer Program for Tissue Doses in Diagnostic Radiology Named without a submission number | |
| * | — | Camird Named without a submission number |
What descends from it? (71)
See all 713 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K172218 (Mim Software, Inc., 2017) has gone furthest, with 67 descendants of its own.
How does its category compare?
All IYX devicesIYX Camera, Scintillation (Gamma): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYX
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · IYX
82in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYX
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYX
1in 2022
MAUDE reports naming product code IYX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 11 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 8 |
| 2010 | 4 | 82 | 0 | 5 |
| 2011 | 3 | 82 | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The purpose of Olinda BXM is to estimate the radiation dose received by internal organs as a result of administering a radiopharmaceutical.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K033960 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033960: Olinda/Exm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033960
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026