CN-Suite™
FDA 510(k) clearance K260563 · decided 2026-08-16
Clearance details
- K-number
- K260563
- Device name
- CN-Suite™
- Applicant
- FIND Surgical Sciences Inc. D/B/A FIND Neuro
- Decision
- Substantially Equivalent
- Date received
- 2026-02-19
- Decision date
- 2026-08-16
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- OLX
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| PreOp v3 (K252565) | Clouds of Care | 2026-02-13 |
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| TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) (K233985) | Megin OY | 2024-05-15 |
| RICOH MEG (K210199) | Ricoh Company, Ltd. | 2021-07-02 |
| EZTrack (K201910) | Neurologic, LLC | 2020-12-22 |
| PreOp (K172858) | Epilog | 2018-01-08 |
| GEOSOURCE (K092844) | Electrical Geodesics, Inc. | 2010-12-21 |
| STELLATE GRIDVIEW (K100126) | Excel-Tech Ltd. (Xltek) | 2010-12-03 |
| ELEKTA NEUROMAG WITH MAXFILTER (K091393) | Elekta Neuromag OY | 2010-10-26 |
| ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING (K081430) | Elekta Neuromag OY | 2008-07-28 |
| MAXINSIGHT (K070358) | Eemagine Medical Imaging Solutions GmbH | 2007-07-30 |
Recalls involving this device
No recalls on record reference this clearance.
Live Atlas record - cite or link it as https://atlasbyauro.com/fda/clearance/cn-suitetm-k260563. Primary-source FDA data, cross-linked and refreshed weekly by Atlas by Auro.
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