FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
CONVIVO In Vivo Pathology Suite
K Number: K211156
·
Decision Dec 29, 2021
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
45
Review Days
254
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
- CONVIVO In Vivo Pathology Suite
- K Number
- K211156
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carl Zeiss Meditec, AG
- Date Received
- April 19, 2021
- Decision Date
- December 29, 2021
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| 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 Carl Zeiss Meditec, AG
| K Number | Device Name | ||
|---|---|---|---|
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) | Jan 10, 2025 | Substantially Equivalent |
| K233911 | VISULAS combi | Sep 6, 2024 | Substantially Equivalent |
| K240215 | BLUE 400; BLUE 400 S | Jun 28, 2024 | Substantially Equivalent |
| K233421 | RESCAN 700 | Mar 8, 2024 | Substantially Equivalent |
| K232944 | CALLISTO eye | Dec 21, 2023 | Substantially Equivalent |
| K232159 | QEVO System | Sep 21, 2023 | Substantially Equivalent |
| K231676 | CALLISTO eye | Aug 28, 2023 | Substantially Equivalent |
| K230858 | QUATERA 700 | Jul 31, 2023 | Substantially Equivalent |
| K213527 | FORUM | Aug 15, 2022 | Substantially Equivalent |
| K211346 | BLUE 400 | Jul 22, 2022 | Substantially Equivalent |