FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
K Number: K191845
·
Decision Sep 6, 2019
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
134
Applicant Total
60
Review Days
58
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Basic Information
- Device Name
- Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
- K Number
- K191845
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Barco N.V.
- Date Received
- July 10, 2019
- Decision Date
- September 6, 2019
- Product Code
- PGY
- 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 |
|---|---|---|---|
| PGY | Display, Diagnostic Radiology | FDA class 2 | Radiology |
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