FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Synq Software Version 1.3
K Number: K232981
·
Decision Oct 11, 2023
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
10
Review Days
20
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Basic Information
- Device Name
- Synq Software Version 1.3
- K Number
- K232981
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synaptive Medical, Inc.
- Date Received
- September 21, 2023
- Decision Date
- October 11, 2023
- Product Code
- LNH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
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|---|---|---|---|
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| K183325 | Modus Nav | Jul 14, 2019 | Substantially Equivalent |
| K180394 | BrightMatter Plan 1.6.0 | Mar 9, 2018 | Substantially Equivalent |
| K160523 | BrightMatter Guide with BrightMatter Pointer | Jun 24, 2016 | Substantially Equivalent |
| K153281 | BrightMatter Guide with Surface Trace Registration | Mar 30, 2016 | Substantially Equivalent |
| K153284 | Synaptive ImageDrive Pro | Mar 29, 2016 | Substantially Equivalent |
| K142024 | BRIGHTMATTER NAVIGATION SYSTEM | Apr 2, 2015 | Substantially Equivalent |
| K140337 | BRIGHTMATTER PLANNING SOFTWARE | Jun 2, 2014 | Substantially Equivalent |