FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DynaCAD
K Number: K212175
·
Decision Aug 2, 2021
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
29
Review Days
21
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Basic Information
- Device Name
- DynaCAD
- K Number
- K212175
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Invivo Corporation
- Date Received
- July 12, 2021
- Decision Date
- August 2, 2021
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by Invivo Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T | Dec 23, 2021 | Substantially Equivalent |
| K212227 | Philips MR Patient Care Portal | Sep 30, 2021 | Substantially Equivalent |
| K193403 | UroNav System | Dec 27, 2019 | Substantially Equivalent |
| K192200 | DynaCAD | Oct 9, 2019 | Substantially Equivalent |
| K182561 | UroNav (Version 3.0) | Oct 19, 2018 | Substantially Equivalent |
| K162177 | dS FootAnkle I6CH 1.5T Coil | Sep 14, 2016 | Substantially Equivalent |
| K162001 | 1.5T and 3.0T 16 CH GE Shoulder Coils | Aug 31, 2016 | Substantially Equivalent |
| K152330 | Expression MR400 MRI Patient Monitoring System | Dec 23, 2015 | Substantially Equivalent |
| K153073 | UroNav (Version 2.0) | Nov 16, 2015 | Substantially Equivalent |
| K133030 | DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) | Jan 22, 2014 | Substantially Equivalent |