510(k) K081624 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
INFX-8000F (INFINIX CSI AND INFINIX DPI)
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Jun 23, 2008 |
| Received | Jun 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081624
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2021 | Canon Medical System, USA, INC. System INFX-8000F Open, Classified |
MQB | None listed |
| Dec 8, 2020 | Canon Medical System, USA, INC. Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F
Catheterization Table CAT-880B
Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and ang Open, Classified |
MQB | None listed |
| Mar 3, 2020 | Canon Medical System, USA, INC. Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration Open, Classified |
MQB | None listed |
| Feb 8, 2019 | Canon Medical System, USA, INC. Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position pati Terminated |
MQB | None listed |
| Dec 29, 2017 | Toshiba American Medical Systems Inc INFX-8000F Fluoroscopic X-Ray Systems Terminated |
MBQ | None listed |
| Mar 25, 2013 | Toshiba American Medical Systems Inc Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures. Terminated |
MQB | None listed |
| Dec 1, 2011 | Toshiba American Medical Systems Inc Model CAT-850B Catheterization Table, a component of the Toshiba INFX-8000 series X-Ray Interventional System.
These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy Terminated |
MQB | None listed |
| Sep 28, 2009 | Toshiba American Medical Systems Inc Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems. Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.