510(k) · Cleared
ClearedIntegrated Stimulus Delivery System Optimum and Premium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Numerics, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Mar 5, 2010 as substantially equivalent to K080515 (Nordicneurolab, 2008) and 1 other predicate after a 130-day review. Its family tree reaches back 3 generations to 2005.
- Decided
- Mar 5, 2010
- Review
- 130 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K043290 (2005). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK043290 Mindstate Functional Data Acquisition Device, Version 1.0Neurognostics, Inc. · 2005
- 2 generations backK073099 Fmri Hardware SystemNordicneurolab · 2007
- 1 generation backK080515 Fmri Hardware SystemNordicneurolab · 2008 · Recalled
- This deviceK093336 Integrated Stimulus Delivery System Optimum and PremiumMedical Numerics, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K043290 | Mindstate Functional Data Acquisition Device, Version 1.0 | Neurognostics, Inc. | 2005 | — |
| −2 | K073099 | Fmri Hardware System | Nordicneurolab | 2007 | — |
| −1 | K080515 | Fmri Hardware System | Nordicneurolab | 2008 | 1 |
| 0 (this device) | K093336 | Integrated Stimulus Delivery System Optimum and Premium | Medical Numerics, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 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 LNH? 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 LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K080515 | Fmri Hardware SystemSummary page 1…tic resonance diagnostic device (21 CFR 892.1000) Class II Product Code LNH Equivalent Device Identification: K080515 FMRI HARDWARE SYSTEM K052571 MINDSTATE FUNCTIONAL DATA… | 2008 |
| * | K052571 | Mindstate Functional Data Acquisition Device (Fdad), Version 1.0Summary page 1…Class II Product Code LNH Equivalent Device Identification: K080515 FMRI HARDWARE SYSTEM K052571 MINDSTATE FUNCTIONAL DATA ACQUISITON DEVICE Device Description: For a patie… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K080515.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, 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 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
The Integrated Stimulus Delivery System (ISDS), both Optimum and Premium models, is indicated for use by trained medical professionals to aid in the performance of functional Magnetic Resonance Imaging (fMRI) examinations based on Blood Oxygen Level Dependent (BOLD) contrast. The ISDS works with GE 1.ST and 3.OT Magnetic Resonance (MR) scanners with BrainWave'TM software installed. The ISDS presents to the patient specific visual and audio stimuli with predetermined order and timing patterns and collects keypad responses; all 1SDS functions are synchronized with the ongoing patient MR imaging examination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093336: Integrated Stimulus Delivery System Optimum and Premium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093336
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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