FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)
K Number: K133030
·
Decision Jan 22, 2014
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
29
Review Days
118
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)
- K Number
- K133030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Invivo Corporation
- Date Received
- September 26, 2013
- Decision Date
- January 22, 2014
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLZ), ordered by most recent decision date.
2D Hip Planning Software
FDA 510(k)
FDA Class 2
·Radiology
CustoMED Viewer
FDA 510(k)
FDA Class 2
·Radiology
Helion Viewer Suite
FDA 510(k)
FDA Class 2
·Radiology
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
FDA 510(k)
FDA Class 2
·Radiology
SubtleHD-PET (1.x)
FDA 510(k)
FDA Class 2
·Radiology
HipGuide (V 1.0.0.0)
FDA 510(k)
FDA Class 2
·Radiology
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 |
| K212175 | DynaCAD | Aug 2, 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 |