FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Modus IR
K Number: K231986
·
Decision Mar 25, 2024
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
198
Applicant Total
10
Review Days
264
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Basic Information
- Device Name
- Modus IR
- K Number
- K231986
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1600
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synaptive Medical, Inc.
- Date Received
- July 5, 2023
- Decision Date
- March 25, 2024
- Product Code
- IZI
- Advisory Committee
- Radiology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | FDA class 2 | Radiology |
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Other Clearances by Synaptive Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |