510(k) K944463 ยท HAW Neurological Stereotaxic Instrument
CRW-1 SYSTEM
| Applicant | Radionics Software Applications, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Oct 26, 1995 |
| Received | Sep 12, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944463
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2015 | Integra LifeSciences Corp. Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra CRW Precision Arc Stereotactic System. Terminated |
HAW | None listed |
| Sep 20, 2012 | Integra LifeSciences Corporation Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts
The CRW stereotactic system is used in conjunction with the HRAIM head ring is a targ Terminated |
HAW | None listed |
| Sep 20, 2012 | Integra LifeSciences Corporation Integra HRAIM Head Ring Assembly with Intubation Mounts
The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only o Terminated |
HAW | None listed |
| Feb 23, 2011 | Integra LifeSciences Corp. Integra Radionics HRAIM Intubation Head Ring Assembly
Ref: HRAIM Head Rings serve as the general stereotactic treatment platform. Head Rings are used to provide a reference frame for instrumentation u Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.