510(k) K072486 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC
| Applicant | Hem Con Medical Technologies, Inc., Portland OR, US |
| Decision | Substantially Equivalent, Aug 6, 2008 |
| Received | Sep 4, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072486
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2012 | Siemens Medical Solutions USA, Inc ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: ARTISTE MV System; ONCOR Avant Garde ONCOR Impression ONCOR Impre Terminated |
IYE | None listed |
| Jul 11, 2011 | Siemens Medical Solutions USA, Inc ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT Therapist v4.1 system with the LANTIS OIS.
The Linear Accelerators are used to deliver X-ray photon and elec Terminated |
IYE | None listed |
| Jun 2, 2011 | Siemens Medical Solutions USA, Inc ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are:
ARTISTE MV System;
ONCOR Avant Garde
ONCOR Impression
ONCOR Impre Terminated |
IYE | None listed |
| May 23, 2011 | Siemens Medical Solutions USA, Inc ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system;
Therapist Express Basic, syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS.
The ONCOR and PRIMUS Terminated |
IYE | None listed |
| May 19, 2011 | Siemens Medical Solutions USA, Inc ARTISTE , ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in combination with syngo RT Oncologist 4.2.
The ONCOR and PRIMUS may be updated to utilize the RT Therapist v4.2 soft Terminated |
IYE | None listed |
| May 12, 2011 | Siemens Medical Solutions USA, Inc ARTISTE / RT Therapist v4.1 system.
The ONCOR and PRIMUS system may be updated to utilize the RT Therapist v4.1 software.
Siemens Healthcare, Concord, CA.
The intended use is to deliver X-ray photon Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.