Hitachi Medical Systems America Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 17
- 510(k) Clearances
- 100
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1282-2021 | Class II | Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doc | March 1, 2021 |
| Z-1341-2020 | Class II | UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be us | January 31, 2020 |
| Z-0271-2020 | Class II | Hitachi Scenaria Whole-body X-ray CT System | October 16, 2019 |
| Z-2839-2018 | Class II | Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole bo | June 29, 2018 |
| Z-2479-2018 | Class II | Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended t | June 18, 2018 |
| Z-0816-2018 | Class II | Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound | October 20, 2017 |
| Z-2090-2017 | Class II | Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) fo | May 2, 2017 |
| Z-1096-2017 | Class II | Hitachi Oasis MRI System - C-Spine Coil | January 6, 2017 |
| Z-2392-2016 | Class II | Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087 | June 30, 2015 |
| Z-1540-2017 | Class II | Hitachi Oasis MRI System | April 16, 2015 |
| Z-1542-2017 | Class II | Hitachi Echelon MRI System | April 16, 2015 |
| Z-1541-2017 | Class II | Hitachi Echelon Oval MRI System | April 16, 2015 |
| Z-2564-2014 | Class II | Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intend | August 18, 2014 |
| Z-2366-2015 | Class II | Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system | April 25, 2014 |
| Z-1559-2013 | Class II | Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelo | January 31, 2013 |
| Z-2254-2012 | Class II | Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Produc | June 15, 2012 |
| Z-2037-2012 | Class II | Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire a | May 4, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K163528 | HITACHI Supria Whole-body X-ray CT System Phase 3 | March 3, 2017 |
| K162079 | TRILLIUM Oval Head Coil 32 | September 16, 2016 |
| K161748 | SUPRIA w/guideShot Option | August 17, 2016 |
| K160152 | Trillium Oval V 5.1 MRI System | May 20, 2016 |
| K153547 | ECHELON Oval V 5.1 MRI System | March 31, 2016 |
| K150595 | SCENARIA Phase 3 Whole-body X-ray CT System | October 30, 2015 |
| K150565 | Supria Whole-body X-ray CT System | September 30, 2015 |
| K151015 | ECHELON Oval V 5.0 MRI System | July 29, 2015 |
| K143537 | Sirius Starmobile tiara | March 6, 2015 |
| K142734 | TRILLIUM Oval MR System | March 2, 2015 |
| K123509 | SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM | March 29, 2013 |
| K113341 | GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM | May 3, 2012 |
| K113145 | ECHELON OVAL MRI SYSTEM | May 1, 2012 |
| K110673 | HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER | September 27, 2011 |
| K101888 | SCENARIA WHOLE-BODY X-RAY CT SYSTEM | April 8, 2011 |
| K110120 | ECHELON RAPID CARDIAC COIL | February 25, 2011 |
| K102889 | HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON | December 20, 2010 |
| K102901 | HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER | October 27, 2010 |
| K093466 | HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS | June 17, 2010 |
| K093044 | OASIS MRI SYSTEM | March 16, 2010 |