510(k) K133580 ยท OWB Interventional Fluoroscopic X-Ray System
ARTIS ONE
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Apr 28, 2014 |
| Received | Nov 21, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133580
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2025 | SIEMENS MEDICAL SOLUTIONS USA, INC ARTIS One Angiographic X-Ray System Open, Classified |
OWB | None listed |
| Apr 27, 2023 | Siemens Medical Solutions USA, Inc ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures.
Material Number: 10848600 Open, Classified |
OWB | None listed |
| Sep 21, 2020 | Siemens Medical Solutions USA, Inc Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray ima Terminated |
OWB | None listed |
| Mar 20, 2018 | Siemens Medical Solutions USA, Inc Artis one fluoroscopic x-ray system and patient table
Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and o Terminated |
OWB | None listed |
| Aug 22, 2017 | Siemens Medical Solutions USA, INC Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional pro Terminated |
OWB | None listed |
| Mar 11, 2016 | Siemens Medical Solutions USA, Inc Artis One, Interventional, Fluoroscopic, x-ray system
Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obe Terminated |
OWB | None listed |
| Feb 17, 2015 | Siemens Medical Solutions USA, Inc Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with t Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.