FDA 510(k)
FDA class 1
Substantially Equivalent
🇪🇸 Spain
Sentinella 102, Sentinella 102 Horus
K Number: K162052
·
Decision Aug 18, 2016
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
3
Review Days
24
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Sentinella 102, Sentinella 102 Horus
- K Number
- K162052
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 892.1100
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- General Equipment For Medical Imaging (Oncovision-
- Date Received
- July 25, 2016
- Decision Date
- August 18, 2016
- Product Code
- IYX
- 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 |
|---|---|---|---|
| IYX | Camera, Scintillation (Gamma) | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYX), ordered by most recent decision date.
QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)
FDA 510(k)
FDA Class 1
·Radiology
3D-RD-S
FDA 510(k)
FDA Class 1
·Radiology
OLINDA EXM
FDA 510(k)
FDA Class 1
·Radiology
Discovery NM 750b Bopsy
FDA 510(k)
FDA Class 1
·Radiology
Sentinella 102; Sentinella 102 Horus
FDA 510(k)
FDA Class 1
·Radiology
ERGO IMAGING SYSTEM
FDA 510(k)
FDA Class 1
·Radiology