510(k) K083282 ยท JAK System, X-Ray, Tomography, Computed
MODEL TSX-301B AQUILION CT SYSTEM
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Dec 12, 2008 |
| Received | Nov 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083282
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2012 | Toshiba American Medical Systems Inc TSX-301A: AQUILION ONE; System, X-Ray, Tomography, Computed
Last four of Serial Number:
2005, 2008, 2010, 2023, 2026, 2034, 2036, 2038, 2048, 2049, 2051, 2052, 2053, 2061, 2063, 2067, 2070, 2071, 207 Terminated |
JAK | None listed |
| Feb 15, 2012 | Toshiba American Medical Systems Inc TSX-301B: AQUILION ONE; System, X-Ray, Tomography, Computed
Last four of Serial Number:
2005, 2008, 2010, 2023, 2026, 2034, 2036, 2038, 2048, 2049, 2051, 2052, 2053, 2061, 2063, 2067, 2070, 2071, 207 Terminated |
JAK | None listed |
| Sep 13, 2011 | Toshiba American Medical Systems Inc TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed
X-Ray Tomography Terminated |
JAK | None listed |
| Jul 29, 2011 | Toshiba American Medical Systems Inc Aquilion One: Aquilion TSX-301A, 64 System, X-Ray, Tomography.
Toshiba American Medical Systems, Inc.
A multislice CT system that supports whole-body scanning. Terminated |
JAK | None listed |
| Jul 29, 2011 | Toshiba American Medical Systems Inc Aquilion One: Aquilion TSX-301B, 64 System, X-Ray, Tomography.
Toshiba American Medical Systems, Inc.
A multislice CT system that supports whole-body scanning. Terminated |
JAK | None listed |
| Mar 16, 2011 | Toshiba American Medical Systems Inc TSX-301A: AQUILION ONE System
AQUILION ONE is a multislice CT system that supports whole body scanning. The system supports simultaneous data acquisitions of 320 slices using the Selectable Slice-thi Terminated |
JAK | None listed |
| Feb 15, 2011 | Toshiba American Medical Systems Inc Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) - Whole Body X-Ray CT Scanner Terminated |
JAK | None listed |
| Mar 2, 2010 | Toshiba American Medical Systems Inc Aquilion One Whole Body X-Ray CT Scanner
Whole body computed tomography scanning Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.