510(k) K891131 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
GAMMAMED 12I
| Applicant | Mick Radio-Nuclear Instruments, Inc., Bronx NY, US |
| Decision | Substantially Equivalent, Aug 7, 1989 |
| Received | Mar 3, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891131
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 1-H63; Product is distributed by Varian Medical Systems Inc., Palo Al Terminated |
JAQ | None listed |
| Dec 1, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 2-H63; Product is distributed by Varian Medical Systems Inc., Palo Al Terminated |
JAQ | None listed |
| Jan 11, 2007 | Varian Medical Systems GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo Alto, CA Terminated |
JAQ | None listed |
| Aug 10, 2006 | Varian Medical Systems GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , part number GM11005400, for the GammaMed model 12i radionuclide applicator system. Terminated |
JAQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.