FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
Radiographic System Challenge X
K Number: K202293
·
Decision Oct 7, 2020
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
26
Review Days
55
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Basic Information
- Device Name
- Radiographic System Challenge X
- K Number
- K202293
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sedecal., Sa.
- Date Received
- August 13, 2020
- Decision Date
- October 7, 2020
- Product Code
- KPR
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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