510(k) K011255 ยท HAW Neurological Stereotaxic Instrument
3D LINE STEROTACTIC HARDWARE ACCESSORIES
| Applicant | 3D Line USA, Inc., Baltimore MD, US |
| Decision | Substantially Equivalent, Dec 20, 2001 |
| Received | Apr 24, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011255
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2013 | Elekta, Inc. Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories
The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors. Terminated |
HAW | None listed |
| Nov 30, 2011 | Elekta, Inc. Stereotactic Circular Collimator
Product Usage: This device is intended to hold a patient's head in a fixed position and to localize and center the output of a linear accelerator (UNAC) to allow rad Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.