FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
Orthopantomograph OP300
K Number: K163423
·
Decision Aug 31, 2017
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
133
Applicant Total
10
Review Days
268
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
- Orthopantomograph OP300
- K Number
- K163423
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Palodex Group OY
- Date Received
- December 6, 2016
- Decision Date
- August 31, 2017
- Product Code
- OAS
- 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 |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OAS), ordered by most recent decision date.
Dental X-ray System
FDA 510(k)
FDA Class 2
·Radiology
Dental Cone Beam Computed Tomography System
FDA 510(k)
FDA Class 2
·Radiology
medXion NEXUS
FDA 510(k)
FDA Class 2
·Radiology
RCT800
FDA 510(k)
FDA Class 2
·Radiology
Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)
FDA 510(k)
FDA Class 2
·Radiology
myray ProXIma X6
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 |
| K162799 | Cliniview | Apr 25, 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 |