510(k) K133553 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
KALARE
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Jun 13, 2014 |
| Received | Nov 19, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133553
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2020 | GE Healthcare, LLC GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjec Terminated |
JAA | None listed |
| Sep 12, 2017 | Toshiba American Medical Systems Inc Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80)
Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including gene Terminated |
JAA | None listed |
| Mar 21, 2016 | Toshiba American Medical Systems Inc Toshiba DRAD-3000E FPD Wireless System
Product Usage The DRAD-3000 is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.