FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)
K Number: K241249
·
Decision Sep 12, 2024
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
133
Applicant Total
10
Review Days
132
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Basic Information
- Device Name
- Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)
- K Number
- K241249
- 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
- May 3, 2024
- Decision Date
- September 12, 2024
- 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 |
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Other Clearances by Palodex Group OY
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |