Hitachi Medical Systems America, Inc.: FDA clearances and approvals
Hitachi Medical Systems America, Inc. has 100 FDA 510(k) clearances (first 1991, latest 2017), across 13 product codes in 2 review panels. Median 510(k) review time: 78 days. openFDA lists 45 product recalls by a recalling firm named Hitachi Medical Systems America, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 180 |
| 2013 | 1 | 136 |
| 2014 | 0 | — |
| 2015 | 5 | 160 |
| 2016 | 4 | 82 |
| 2017 | 1 | 77 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Hitachi Medical Systems America, Inc.'s cleared 510(k)s took a median 77 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 54 | 54 |
| MOS | Coil, Magnetic Resonance, Specialty | 18 | 18 |
| JAK | System, X-Ray, Tomography, Computed | 12 | 12 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 5 | 5 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| LNI | System, Nuclear Magnetic Resonance Spectroscopic | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| IZI | System, X-Ray, Angiographic | 1 | 1 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
Plus 3 more product codes.
Review panels
- Radiology (99)
- Anesthesiology (1)
Most recent Hitachi Medical Systems America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163528 | HITACHI Supria Whole-body X-ray CT System Phase 3 | JAK | 2017-03-03 | 77 |
| K162079 | TRILLIUM Oval Head Coil 32 | MOS | 2016-09-16 | 51 |
| K161748 | SUPRIA w/guideShot Option | JAK | 2016-08-17 | 54 |
| K160152 | Trillium Oval V 5.1 MRI System | LNH | 2016-05-20 | 119 |
| K153547 | ECHELON Oval V 5.1 MRI System | LNH | 2016-03-31 | 111 |
| K150595 | SCENARIA Phase 3 Whole-body X-ray CT System | JAK | 2015-10-30 | 235 |
| K150565 | Supria Whole-body X-ray CT System | JAK | 2015-09-30 | 208 |
| K151015 | ECHELON Oval V 5.0 MRI System | LNH | 2015-07-29 | 104 |
| K143537 | Sirius Starmobile tiara | IZL | 2015-03-06 | 81 |
| K142734 | TRILLIUM Oval MR System | LNH | 2015-03-02 | 160 |
90 earlier clearances. See the full list in Caduvo.
Recalls
45 product recalls in 38 recall events; 0 initiated in the last five years. Most recent: 2021-03-01.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Hitachi Medical Systems America, Inc.'s product codes (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNI)
Frequently asked questions
How many FDA 510(k) clearances does Hitachi Medical Systems America, Inc. have?
Hitachi Medical Systems America, Inc. has 100 FDA 510(k) clearances (first 1991, latest 2017), across 13 product codes in 2 review panels.
How long does FDA take to clear Hitachi Medical Systems America, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hitachi Medical Systems America, Inc.'s cleared 510(k)s is 78 days.
What devices does Hitachi Medical Systems America, Inc. make?
Its most frequent FDA product codes are LNH (System, Nuclear Magnetic Resonance Imaging, 54); MOS (Coil, Magnetic Resonance, Specialty, 18); JAK (System, X-Ray, Tomography, Computed, 12).
Has Hitachi Medical Systems America, Inc. had device recalls?
openFDA lists 45 product recalls in 38 recall events by a recalling firm whose name matches Hitachi Medical Systems America, Inc; the most recent began 2021-03-01. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 100 Hitachi Medical Systems America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Hitachi Medical Systems America, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.