510(k) · Cleared
ClearedOlinda Exm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hermes Medical Solutions AB · IYX Camera, Scintillation (Gamma)
Cleared on Jul 19, 2017 as substantially equivalent to K033960 (Vanderbilt University, 2004) after a 203-day review. Its family tree reaches back 1 generation to 2004. 56 later devices descend from it.
- Decided
- Jul 19, 2017
- Review
- 203 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033960 (2004). 56 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK033960 Olinda/ExmVanderbilt University · 2004
- This deviceK163687 Olinda ExmHermes Medical Solutions AB · 2017
- Descendant · cites it directly · 53 of its ownK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- Descendant · 2 generations on · 30 of its ownK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- Descendant · 2 generations on · 14 of its ownK190379 MIM on LinuxMim Software, Inc. · 2019
- Descendant · 3 generations on · 6 of its ownK193562 AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. · 2020
- Descendant · 3 generations on · 6 of its ownK193252 Contour ProtegeAIMim Software, Inc. · 2020
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K182624MIM - MRT DosimetryMim Software, Inc. · 2018 · cites it directly53descendants
- K191928AccuContourXiamen Manteia Technology, Ltd. · 2020 · 2 generations on30descendants
- K190379MIM on LinuxMim Software, Inc. · 2019 · 2 generations on14descendants
- K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. · 2020 · 3 generations on6descendants
- K193252Contour ProtegeAIMim Software, Inc. · 2020 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033960 | Olinda/Exm | Vanderbilt University | 2004 | — |
| 0 (this device) | K163687 | Olinda Exm | Hermes Medical Solutions AB | 2017 | — |
| +1 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| +2 | K191928 | AccuContour | Xiamen Manteia Technology, Ltd. | 2020 | — |
| +2 | K190379 | MIM on Linux | Mim Software, Inc. | 2019 | — |
| +3 | K193562 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +3 | K193252 | Contour ProtegeAI | Mim Software, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 7 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 8 | 0 |
| 2025 | 9 | 0 |
| 2026 | 9 | 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? (1)
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 |
|---|---|---|---|
| * | K033960 | Olinda/ExmSummary page 4…) camera, Class I, 21CFR892.1100. D. Legally marketed device (predicate device): Following legally marketed device has been used for comparison. • OLINDA/EXM® v1.1 (K033960) E. Description of the device that is subject of this premarket notification: The OLINDA/EXM® v2.0 is a modification of OLINDA/E… | 2004 |
What descends from it? (56)
See all 565 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?
How does its category compare?
All IYX devicesIYX Camera, Scintillation (Gamma): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 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.
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/K163687 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163687: 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/K163687
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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