FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
Cliniview
K Number: K162799
·
Decision Apr 25, 2017
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
10
Review Days
202
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
- Cliniview
- K Number
- K162799
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Palodex Group OY
- Date Received
- October 5, 2016
- Decision Date
- April 25, 2017
- 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 Palodex Group OY
| K Number | Device Name | ||
|---|---|---|---|
| K241249 | Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D) | Sep 12, 2024 | Substantially Equivalent |
| K230505 | Orthopantomograph OP 3D LX | Jun 9, 2023 | Substantially Equivalent |
| K180947 | Orthopantomograph OP 3D | Jun 7, 2018 | Substantially Equivalent |
| K173646 | FS Ergo | Dec 19, 2017 | Substantially Equivalent |
| K163423 | Orthopantomograph OP300 | Aug 31, 2017 | Substantially Equivalent |
| K170813 | ORTHOPANTOMOGRAPH OP 3D | Apr 7, 2017 | Substantially Equivalent |
| K133544 | OP300 | Mar 26, 2014 | Substantially Equivalent |
| K130297 | SCANORA 3DX | May 29, 2013 | Substantially Equivalent |
| K122018 | OP300 | Dec 10, 2012 | Substantially Equivalent |