510(k) K010435 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS BV PULSERA/ENDURA
| Applicant | Philips Medical Systems, Inc., Da Best, NL |
| Decision | Substantially Equivalent, Mar 12, 2001 |
| Received | Feb 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010435
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2024 | Philips North America BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems. Open, Classified |
OWB | None listed |
| Nov 12, 2021 | Philips North America Llc BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system.
Model Number: 718075 Open, Classified |
OWB | None listed |
| Nov 12, 2021 | Philips North America Llc BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system.
Model Number: 718095 Open, Classified |
OWB | None listed |
| Oct 27, 2011 | Philips Healthcare Inc. Philips BV Pulsera Fluoroscopic Image Intensified X-ray
Catalog Number: 718095
Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system. Terminated |
JAA | None listed |
| Oct 27, 2011 | Philips Healthcare Inc. Philips BV Endura Fluoroscopic Image Intensified X-ray
Catalog Number: 718074
Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system. Terminated |
JAA | None listed |
| Oct 27, 2011 | Philips Healthcare Inc. Philips Verardius Image Intensified X-ray
Catalog Number: 718130
Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system. Terminated |
JAA | None listed |
| Mar 8, 2011 | Philips Medical Systems North America Co. Phillips Philips BV Endura, Rel. 2, 718074.
Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications. Terminated |
IXL | None listed |
| Mar 8, 2011 | Philips Medical Systems North America Co. Phillips Philips BV Pulsera, Rel. 2.3, 718095.
Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications. Terminated |
IXL | None listed |
| Oct 25, 2010 | Philips Medical Systems North America Co. Phillips Philips BV Pulsera R2.2 Mobile X-ray system. The Type Product Code 718094 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device Terminated |
JAA | None listed |
| Oct 25, 2010 | Philips Medical Systems North America Co. Phillips Philips BV Endura R2.2 Mobile X-ray system. The Type Product Code 718074 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device b Terminated |
JAA | None listed |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips BV Pulsera Mobile X-Ray system with the extended rotation option. Terminated |
JAA | None listed |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips BV Endura Mobile X-Ray system with the extended rotation option. Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.