FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)
K Number: K183606
·
Decision Apr 8, 2019
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
5
Review Days
103
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Basic Information
- Device Name
- Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)
- K Number
- K183606
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scandidos AB
- Date Received
- December 26, 2018
- Decision Date
- April 8, 2019
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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Other Clearances by Scandidos AB
| K Number | Device Name | ||
|---|---|---|---|
| K223234 | Delta4 Insight | Jan 16, 2024 | Substantially Equivalent |
| K151426 | ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ | Jan 29, 2016 | Substantially Equivalent |
| K151180 | ScandiDos Delta4 Phantom+ | Aug 19, 2015 | Substantially Equivalent |
| K052920 | DELTA4 | Jan 12, 2006 | Substantially Equivalent |