FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Accipiolx
K Number: K182177
·
Decision Oct 26, 2018
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
85
Applicant Total
1
Review Days
77
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Basic Information
- Device Name
- Accipiolx
- K Number
- K182177
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2080
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maxq-Al , Ltd.
- Date Received
- August 10, 2018
- Decision Date
- October 26, 2018
- Product Code
- QAS
- 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 |
|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | FDA class 2 | Radiology |
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