Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hitachi Medical Systems America, Inc. · Predicate Candidate Screening
100 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
199 days90th percentile
100clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163528 | HITACHI Supria Whole-body X-ray CT System Phase 3 | Hitachi Medical Systems America, Inc. | 2017-03-03 | 77 | 0 |
| K162079 | TRILLIUM Oval Head Coil 32 | Hitachi Medical Systems America, Inc. | 2016-09-16 | 51 | 0 |
| K161748 | SUPRIA w/guideShot Option | Hitachi Medical Systems America, Inc. | 2016-08-17 | 54 | 0 |
| K160152 | Trillium Oval V 5.1 MRI System | Hitachi Medical Systems America, Inc. | 2016-05-20 | 119 | 0 |
| K153547 | ECHELON Oval V 5.1 MRI System | Hitachi Medical Systems America, Inc. | 2016-03-31 | 111 | 2 |
| K150595 | SCENARIA Phase 3 Whole-body X-ray CT System | Hitachi Medical Systems America, Inc. | 2015-10-30 | 235 | 0 |
| K150565 | Supria Whole-body X-ray CT System | Hitachi Medical Systems America, Inc. | 2015-09-30 | 208 | 0 |
| K151015 | ECHELON Oval V 5.0 MRI System | Hitachi Medical Systems America, Inc. | 2015-07-29 | 104 | 1 |
| K143537 | Sirius Starmobile tiara | Hitachi Medical Systems America, Inc. | 2015-03-06 | 81 | 0 |
| K142734 | TRILLIUM Oval MR System | Hitachi Medical Systems America, Inc. | 2015-03-02 | 160 | 0 |
| K123509 | SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM | Hitachi Medical Systems America, Inc. | 2013-03-29 | 136 | 0 |
| K113341 | GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM | Hitachi Medical Systems America, Inc. | 2012-05-03 | 171 | 0 |
| K113145 | ECHELON OVAL MRI SYSTEM | Hitachi Medical Systems America, Inc. | 2012-05-01 | 189 | 3 |
| K110673 | HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER | Hitachi Medical Systems America, Inc. | 2011-09-27 | 202 | 0 |
| K101888 | SCENARIA WHOLE-BODY X-RAY CT SYSTEM | Hitachi Medical Systems America, Inc. | 2011-04-08 | 275 | 1 |
| K110120 | ECHELON RAPID CARDIAC COIL | Hitachi Medical Systems America, Inc. | 2011-02-25 | 38 | 0 |
| K102889 | HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODE | Hitachi Medical Systems America, Inc. | 2010-12-20 | 81 | 0 |
| K102901 | HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER | Hitachi Medical Systems America, Inc. | 2010-10-27 | 27 | 1 |
| K093466 | HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VIS | Hitachi Medical Systems America, Inc. | 2010-06-17 | 223 | 1 |
| K093044 | OASIS MRI SYSTEM | Hitachi Medical Systems America, Inc. | 2010-03-16 | 167 | 0 |
| K091103 | GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS | Hitachi Medical Systems America, Inc. | 2009-06-15 | 60 | 0 |
| K083533 | ECHELON C MRI SYSTEM | Hitachi Medical Systems America, Inc. | 2009-02-17 | 81 | 1 |
| K083086 | ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG | Hitachi Medical Systems America, Inc. | 2008-12-05 | 50 | 0 |
| K081745 | ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT | Hitachi Medical Systems America, Inc. | 2008-08-12 | 54 | 0 |
| K081198 | ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TO | Hitachi Medical Systems America, Inc. | 2008-06-18 | 51 | 0 |
| K080062 | OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV | Hitachi Medical Systems America, Inc. | 2008-02-11 | 33 | 0 |
| K072279 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE | Hitachi Medical Systems America, Inc. | 2007-09-21 | 36 | 4 |
| K071806 | ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM | Hitachi Medical Systems America, Inc. | 2007-08-28 | 57 | 1 |
| K071506 | ECHELON SPECTROSCOPY PACKAGE | Hitachi Medical Systems America, Inc. | 2007-06-28 | 27 | 0 |
| K063518 | HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER | Hitachi Medical Systems America, Inc. | 2006-12-21 | 30 | 0 |
| K063513 | ECHELON MR-RCC-150 CARDIAC COIL | Hitachi Medical Systems America, Inc. | 2006-12-12 | 21 | 0 |
| K062556 | ECHELON SHOULDER COIL | Hitachi Medical Systems America, Inc. | 2006-10-05 | 36 | 0 |
| K061950 | HHF1 ECHELON MULTI-PURPOSE COIL | Hitachi Medical Systems America, Inc. | 2006-08-18 | 39 | 0 |
| K053148 | CXR16 | Hitachi Medical Systems America, Inc. | 2006-02-17 | 99 | 0 |
| K053309 | ALTAIRE INTERVENTIONAL MR PACKAGE | Hitachi Medical Systems America, Inc. | 2006-01-24 | 57 | 0 |
| K052172 | HHF1 MAGNETIC RESONANCE IMAGING SYSTEM | Hitachi Medical Systems America, Inc. | 2005-09-27 | 49 | 3 |
| K050602 | ALTAIRE | Hitachi Medical Systems America, Inc. | 2005-04-07 | 29 | 0 |
| K050307 | AIRIS ELITE RAPID BODY COIL | Hitachi Medical Systems America, Inc. | 2005-02-28 | 20 | 0 |
| K042428 | SCEPTREP3 PET/CT | Hitachi Medical Systems America, Inc. | 2004-09-17 | 9 | 2 |
| K040902 | HITACHI PRESTO | Hitachi Medical Systems America, Inc. | 2004-04-21 | 14 | 4 |
| K033248 | HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM | Hitachi Medical Systems America, Inc. | 2003-10-20 | 13 | 0 |
| K032232 | AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE | Hitachi Medical Systems America, Inc. | 2003-09-29 | 70 | 2 |
| K032503 | EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER | Hitachi Medical Systems America, Inc. | 2003-08-22 | 9 | 0 |
| K022390 | HITACHI ALTAIRE | Hitachi Medical Systems America, Inc. | 2002-10-11 | 80 | 5 |
| K021751 | ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM | Hitachi Medical Systems America, Inc. | 2002-08-15 | 79 | 0 |
| K021314 | SCEPTRE-VS | Hitachi Medical Systems America, Inc. | 2002-07-02 | 68 | 0 |
| K014240 | PRONTO | Hitachi Medical Systems America, Inc. | 2002-03-22 | 86 | 0 |
| K011320 | ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM | Hitachi Medical Systems America, Inc. | 2001-08-09 | 100 | 0 |
| K002420 | HITACHI ALTAIRE | Hitachi Medical Systems America, Inc. | 2000-10-17 | 70 | 8 |
| K001334 | HITACHI AIRIS II | Hitachi Medical Systems America, Inc. | 2000-07-06 | 70 | 3 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda