FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Giotto Class (Models - 3000X-YY and 4000X-YY)
K Number: K200424
·
Decision Jun 18, 2020
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
54
Applicant Total
2
Review Days
119
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Basic Information
- Device Name
- Giotto Class (Models - 3000X-YY and 4000X-YY)
- K Number
- K200424
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1715
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ims Giotto S.P.A.
- Date Received
- February 20, 2020
- Decision Date
- June 18, 2020
- Product Code
- MUE
- 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 |
|---|---|---|---|
| MUE | Full Field Digital, System, X-Ray, Mammographic | FDA class 2 | Radiology |
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Other Clearances by Ims Giotto S.P.A.
| K Number | Device Name | ||
|---|---|---|---|
| K203509 | SMART FINDER | Jul 14, 2021 | Substantially Equivalent |