FDA 510(k)
FDA class 1
Substantially Equivalent
🇪🇸 Spain
Sentinella 102; Sentinella 102 Horus
K Number: K143156
·
Decision Nov 18, 2014
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
3
Review Days
15
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Basic Information
- Device Name
- Sentinella 102; Sentinella 102 Horus
- K Number
- K143156
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1100
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- General Equipment For Medical Imaging (Oncovision-
- Date Received
- November 3, 2014
- Decision Date
- November 18, 2014
- Product Code
- IYX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYX | Camera, Scintillation (Gamma) | FDA class 1 | Radiology |
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