FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
BrightMatter Plan 1.6.0
K Number: K180394
·
Decision Mar 9, 2018
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
10
Review Days
24
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Basic Information
- Device Name
- BrightMatter Plan 1.6.0
- K Number
- K180394
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synaptive Medical, Inc.
- Date Received
- February 13, 2018
- Decision Date
- March 9, 2018
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by Synaptive Medical, Inc.
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|---|---|---|---|
| K231986 | Modus IR | Mar 25, 2024 | Substantially Equivalent |
| K232981 | Synq Software Version 1.3 | Oct 11, 2023 | Substantially Equivalent |
| K200327 | Evry | Apr 29, 2020 | Substantially Equivalent |
| K183325 | Modus Nav | Jul 14, 2019 | 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 |