510(k) · Cleared
ClearedInspira HD, Model: NL1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurologica Corporation · KPS System, Tomography, Computed, Emission
Cleared on Aug 27, 2009 as substantially equivalent to K022240 (Ge Medical Systems, Inc., 2002) and 2 other predicates after a 155-day review. Its family tree reaches back 3 generations to 1992. 1 of the 26 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- Aug 27, 2009
- Review
- 155 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K915470 (1992). 15 ancestors in all, the oldest K780395 (1978). 10 later devices descend from it, 1 citing it directly. 1 of the 26 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK915470 Optima Nuclear Tomography StystemGeneral Electric Co. · 1992
- 2 generations backK962738 Millennium MT and Millennium MG Nuclear Medicine SystemsGE Medical Systems · 1996 · Recalled (Class I)
- 1 generation backK022240 Mobile Millennium MG SystemGe Medical Systems, Inc. · 2002
- This deviceK090811 Inspira HD, Model: NL1000Neurologica Corporation · 2009
- Descendant · cites it directly · 9 of its ownK102677 Bodytom NL 4000Neurologica Corporation · 2011
- Descendant · 2 generations on · 4 of its ownK170238 BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017
- Descendant · 3 generations on · 2 of its ownK213649 BodyTom 64Neurologica Corporation · 2022
- Descendant · 2 generations on · 2 of its ownK131431 Airo CT SystemMobius Imaging, LLC · 2013 · Recalled
- Descendant · 4 generations on · 1 of its ownK242811 BodyTom 64Neurologica Corporation, A Subsidiary of Samsung · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K962738 Millennium MT and Millennium MG Nuclear Medicine…2 generations back · 1996
Most influential descendants
Showing 5 of 10 · See all- K102677Bodytom NL 4000Neurologica Corporation · 2011 · cites it directly9descendants
- K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017 · 2 generations on4descendants
- K213649BodyTom 64Neurologica Corporation · 2022 · 3 generations on2descendants
- K131431Airo CT SystemMobius Imaging, LLC · 2013 · 2 generations on2descendants
- K242811BodyTom 64Neurologica Corporation, A Subsidiary of Samsung · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915470 | Optima Nuclear Tomography Stystem | General Electric Co. | 1992 | — |
| −2 | K962738 | Millennium MT and Millennium MG Nuclear Medicine Systems | GE Medical Systems | 1996 | Class I |
| −1 | K022240 | Mobile Millennium MG System | Ge Medical Systems, Inc. | 2002 | — |
| 0 (this device) | K090811 | Inspira HD, Model: NL1000 | Neurologica Corporation | 2009 | — |
| +1 | K102677 | Bodytom NL 4000 | Neurologica Corporation | 2011 | — |
| +2 | K170238 | BodyTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2017 | — |
| +3 | K213649 | BodyTom 64 | Neurologica Corporation | 2022 | — |
| +2 | K131431 | Airo CT System | Mobius Imaging, LLC | 2013 | 1 |
| +4 | K242811 | BodyTom 64 | Neurologica Corporation, A Subsidiary of Samsung | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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.
1 device in this family has a Class I recall. 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 KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.7 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K022240 | Mobile Millennium MG SystemSummary page 2…Abbreviated Premarket 5 10(k) Submission Page 1q Predicate Devices: 1. GE Medical Systems, Millennium Mobile MG Imaging System - K022240 2. Union Carbide, Imager, Body Section, Radionuclide - K780395 3. NeuroLogica Corporation, CereTo MTM Model NL3000 - K0… | 2002 |
| * | K780395 | Imager, Body Section, RadionuclideSummary page 2…Predicate Devices: 1. GE Medical Systems, Millennium Mobile MG Imaging System - K022240 2. Union Carbide, Imager, Body Section, Radionuclide - K780395 3. NeuroLogica Corporation, CereTo MTM Model NL3000 - K051765 NeuroLogica Corporation JinSPira. HD' h Abbreviated Premna… | 1978 |
| * | K051765 | Ceretom, Model NL3000Summary page 2…lennium Mobile MG Imaging System - K022240 2. Union Carbide, Imager, Body Section, Radionuclide - K780395 3. NeuroLogica Corporation, CereTo MTM Model NL3000 - K051765 NeuroLogica Corporation JinSPira. HD' h Abbreviated Premnarket 510(k).Submission Page 15' Device Descriptio… | 2005 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102677 | Bodytom NL 4000 | 2011 | 9 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K962738Millennium MT and Millennium MG Nuclear Medicine SystemsGE Medical Systems · 1996 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 3 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K102677 (Neurologica Corporation, 2011) has gone furthest, with 9 descendants of its own.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, 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 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
The inSPira HD is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel for anatomy that can be imaged in the 21cm field of view, primarily brain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090811 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090811: Inspira HD, Model: NL1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090811
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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