510(k) K100890 ยท IYE Accelerator, Linear, Medical
VARIAN HIGH ENERGY LINEAR ACCELERATOR
| Applicant | Varian Medical Systems, Palo Alto CA, US |
| Decision | Substantially Equivalent, Jul 13, 2010 |
| Received | Mar 31, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100890
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2013 | Varian Medical Systems, Inc. Oncology Systems Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX.
Product Usage:
The Varian High Energy Accelerator is intended to provide stereota Terminated |
IYE | None listed |
| Nov 9, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian Clinac, Trilogy, Trilogy Tx and Novalis linear accelerators.
Manufactured by Varian Medical System, Palo Alto, CA.
Varian High Energy Linear Accelerator is indicated for stereotactic radiosur Terminated |
IYE | None listed |
| Sep 14, 2011 | Varian Medical Systems, Inc. Varian Medical Systems Inc., Millennium and HD-120 MultiLeaf Collimators (MLC), a component of the Clinac, All Varian Clinac using the collimator cover P/N 1106900-xx, Model Numbers:
H14, H18, H27, H Terminated |
IYE | None listed |
| Aug 10, 2011 | Varian Medical Systems, Inc. Oncology Systems Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators.
Varian Medical Systems, Inc. Oncology Systems
Intended for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and Terminated |
IYE | None listed |
| Jul 28, 2011 | Varian Medical Systems, Inc. Oncology Systems Clinac Linear Accelerators;
Varian Medical Systems, Palo Alto, CA.
Radiation Therapy intended to deliver megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and r Terminated |
IYE | None listed |
| Jul 11, 2011 | Varian Medical Systems, Inc. Oncology Systems Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear Accelerators Drive Stands
Indicated for sterostatic radiosurgery and precision radiotherapy for lesions, tumors and conditions anyw Terminated |
IYE | None listed |
| Jul 8, 2011 | Varian Medical Systems, Inc. Oncology Systems Clinac Linear Accelerator;
Model numbers H14, H27 and H29.
Product Usage: Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tu Terminated |
IYE | None listed |
| May 20, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian brand Clinac and TrueBeam, High Energy Linear Accelerator, Model Numbers: H14, H19, H29; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
Indicated for ste Terminated |
IYE | None listed |
| May 13, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian brand Clinac, Medical Linear Accelerator, All Varian Clinac with Model Numbers: H14, H18, H26, H27, H28, H29, Hcx; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Terminated |
IYE | None listed |
| Feb 24, 2011 | Varian Medical Systems, Inc. Oncology Systems Clinac High Energy Medical Linear Accelerator, a Trilogy Radiotherapy Delivery System; Model #s: H14, H18, H27, H29, HCX; Product is manufactured and distributed by Varian Medical Systems Inc., Palo A Terminated |
IYE | None listed |
| Feb 8, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian High Energy Linear Accelerator:
Varian Medical Systems, Palo Alto, CA 94304
Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in t Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.