The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Guideshot Option For Cxr4 And Eclos Ct Systems.
| Device ID | K091103 |
| 510k Number | K091103 |
| Device Name: | GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Contact | Doug Thistlethwaite |
| Correspondent | Doug Thistlethwaite HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-16 |
| Decision Date | 2009-06-15 |
| Summary: | summary |