510(k) K050190 ยท KXJ Table, Radiologic
APOLLO
| Applicant | Villa Sistemi Medicali S.P.A., Franklin Park IL, US |
| Decision | Substantially Equivalent, Mar 25, 2005 |
| Received | Jan 27, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K050190
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2019 | Villa Sistemi Medicali S.P.A. Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures. Open, Classified |
KXJ | None listed |
| Nov 4, 2019 | Villa Sistemi Medicali S.P.A. Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationa Open, Classified |
KXJ | None listed |
| Nov 4, 2019 | Villa Sistemi Medicali S.P.A. Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows to perform general radiographic and fluoroscopic examinations. The system Open, Classified |
KXJ | None listed |
| Nov 4, 2019 | Villa Sistemi Medicali S.P.A. Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment that can be used to perform general radiographic and fluoroscopic examinations. The system Open, Classified |
KXJ | None listed |
| Dec 27, 2016 | Villa Sistemi Medicali S.P.A. Juno DRF; Model: 709020
Product Usage:
General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures Terminated |
KXJ | None listed |
| Dec 27, 2016 | Villa Sistemi Medicali S.P.A. Apollo; Models: 9784000131
9784000231
9784020131
9784020231
9784100231
9784120131
9784120231
9784130131
Product Usage:
General, multi-function x-ray systems capable of routine radiographs and general Terminated |
KXJ | None listed |
| Dec 27, 2016 | Villa Sistemi Medicali S.P.A. Apollo DRF; Model: 9784220831
Product Usage:
General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures Terminated |
KXJ | None listed |
| Dec 27, 2016 | Villa Sistemi Medicali S.P.A. Apollo EZ; Model: 9784152036
Product Usage:
General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures Terminated |
KXJ | None listed |
| Feb 19, 2016 | Villa Radiology Systems LLC Juno DRF; Model: 709020
Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. Open, Classified |
KXJ | None listed |
| Feb 19, 2016 | Villa Radiology Systems LLC Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131
Multi-function x-ray systems capable of routine radiograph and general fluoroscopy proce Open, Classified |
KXJ | None listed |
| Feb 19, 2016 | Villa Radiology Systems LLC Apollo DRF: Model: 9784220831
Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. Open, Classified |
KXJ | None listed |
| Feb 19, 2016 | Villa Radiology Systems LLC Apollo EZ: Model: 9784152036
Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. Open, Classified |
KXJ | None listed |
| Mar 6, 2015 | Villa Radiology Systems LLC Juno DFR X-ray system Terminated |
KXJ | None listed |
| Sep 13, 2013 | Villa Radiology Systems LLC Juno DRF System. Mobile X-ray system
These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures Terminated |
KXJ | None listed |
| Jan 28, 2013 | Philips Healthcare Inc. Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose
Model: 70920
Product Usage:
Universal R/F, general use Terminated |
RCA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.