# K093336: Integrated Stimulus Delivery System Optimum and Premium

- Pathway: 510(k) (Traditional)
- Applicant: Medical Numerics, Inc.
- Decided: Mar 5, 2010 after 130 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K043290 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080515: Fmri Hardware System, Nordicneurolab (2008) Summary page 1.
- K052571: Mindstate Functional Data Acquisition Device (Fdad), Version 1.0, Neurognostics, Inc. (2005) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K093336
Methodology: https://510kreport.com/methodology