510(k) · Cleared
ClearedImager, Body Section, Radionuclide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Union Carbide Corp. · IYW Scanner, Rectilinear, Nuclear
Cleared on Mar 31, 1978 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Mar 31, 1978
- Review
- 18 days
- Class
- Class I
- Product code
- IYW
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK780395 Imager, Body Section, RadionuclideUnion Carbide Corp. · 1978
- Descendant · cites it directly · 10 of its ownK090811 Inspira HD, Model: NL1000Neurologica Corporation · 2009
- Descendant · 2 generations on · 9 of its ownK102677 Bodytom NL 4000Neurologica Corporation · 2011
- Descendant · 3 generations on · 4 of its ownK170238 BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017
- Descendant · 4 generations on · 2 of its ownK213649 BodyTom 64Neurologica Corporation · 2022
- Descendant · 3 generations on · 2 of its ownK131431 Airo CT SystemMobius Imaging, LLC · 2013 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K090811Inspira HD, Model: NL1000Neurologica Corporation · 2009 · cites it directly10descendants
- K102677Bodytom NL 4000Neurologica Corporation · 2011 · 2 generations on9descendants
- K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017 · 3 generations on4descendants
- K213649BodyTom 64Neurologica Corporation · 2022 · 4 generations on2descendants
- K131431Airo CT SystemMobius Imaging, LLC · 2013 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K780395 | Imager, Body Section, Radionuclide | Union Carbide Corp. | 1978 | — |
| +1 | K090811 | Inspira HD, Model: NL1000 | Neurologica Corporation | 2009 | — |
| +2 | K102677 | Bodytom NL 4000 | Neurologica Corporation | 2011 | — |
| +3 | K170238 | BodyTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2017 | — |
| +4 | K213649 | BodyTom 64 | Neurologica Corporation | 2022 | — |
| +3 | K131431 | Airo CT System | Mobius Imaging, LLC | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090811 | Inspira HD, Model: NL1000 | 2009 | 10 |
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, K090811 (Neurologica Corporation, 2009) has gone furthest, with 10 descendants of its own.
How does its category compare?
All IYW devicesIYW Scanner, Rectilinear, Nuclear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYW
FDA has decided no IYW device since 2007.
Median 510(k) review, days · IYW
Too few IYW 510(k)s in any year since 2007 to give a median.
Recalls per year · IYW
No recall names IYW since 2007.
Adverse event reports per year · IYW
No MAUDE report names IYW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K780395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K780395: Imager, Body Section, Radionuclide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K780395
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026