Qsi 9500
FDA 510(k) K904294 · Quantified Signal Imaging, Inc.
510(k) numberK904294
Submission
- Device name
- Qsi 9500
- Applicant
- Quantified Signal Imaging, Inc.
Toronto, CA - Received
- September 19, 1990
- Decision date
- July 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- OLU – Normalizing Quantitative Electroencephalograph Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.
Other 510(k)s with product code OLU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253015 | Cognitive Function Neuroimaging (cfNI) Software (1.0.0)OLU · Traditional | VoxNeuro, Inc. | 06/12/2026SE |
| K240420 | NeuroField Analysis SuiteOLU · Traditional | Neurofield, Inc. | 09/20/2024SE |
| K222838 | iSyncBrain©-COLU · Traditional | iMediSync, Inc. | 03/16/2023SE |
| K212684 | BrainView QEEG SoftwareOLU · Traditional | Medeia, Inc. | 01/28/2023SE |
| K202588 | BNA PlatformOLU · Traditional | Elminda, Ltd. | 12/07/2020SE |
| K191432 | cortiQ PROOLU · Traditional | G.Tec Medical Engineering GmbH | 01/24/2020SE |
| K171414 | qEEG-ProOLU · Traditional | Brainmaster Technologies, Inc. | 07/01/2018SE |
| K121119 | Bna Analysis SystemOLU · Traditional | Eiminda , Ltd. | 07/25/2014SE |
| K112077 | Hbidb - Human Brian Index SoftwareOLU · Traditional | Corscience GmbH & Co. KG | 03/09/2012SE |
| K050192 | BRC Software ProductOLU · Traditional | Brc Operations Pty Limited | 10/20/2005SE |
More from Brc Operations Pty Limited
Questions and answers
When was Qsi 9500 cleared by the FDA?
Qsi 9500 (K904294) received a 510(k) decision of Substantially Equivalent on July 30, 1991, 314 days after the submission was received.
What is the product code of K904294?
The FDA product code is OLU – Normalizing Quantitative Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.