APOLLO
FDA 510(k) clearance K050190 · decided 2005-03-25
Clearance details
- K-number
- K050190
- Device name
- APOLLO
- Applicant
- Villa Sistemi Medicali S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2005-01-27
- Decision date
- 2005-03-25
- Days to decision
- 57 days
- Clearance type
- Abbreviated
- Product code
- KXJ
- Device class
- 2
- Regulation number
- 892.1980
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Franklin Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Juno DFR X-ray system recall (Z-1079-2015) | Villa Radiology Systems LLC | 2015-03-06 |
| Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capab recall (Z-2160-2013) | Villa Radiology Systems LLC | 2013-09-13 |
| Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Us recall (Z-0702-2013) | Philips Healthcare Inc. | 2013-01-28 |