FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
aPROMISE
K Number: K211655
·
Decision Jul 27, 2021
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
3
Review Days
60
Basic Information
- Device Name
- aPROMISE
- K Number
- K211655
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EXINI Diagnostics AB
- Date Received
- May 28, 2021
- Decision Date
- July 27, 2021
- 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 |
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