RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR
FDA 510(k) clearance K161345 · decided 2016-07-06
Clearance details
- K-number
- K161345
- Device name
- RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR
- Applicant
- Sedecal., Sa.
- Decision
- Substantially Equivalent
- Date received
- 2016-05-13
- Decision date
- 2016-07-06
- Days to decision
- 54 days
- Clearance type
- Special
- Product code
- IZL
- Device class
- 2
- Regulation number
- 892.1720
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Algete, ES
- Third-party review
- No
- Expedited review
- No
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