Hitachi
- Primary DI
- 04580292766441
- Brand
- Hitachi
- Company
- HITACHI, LTD.
- Model
- Scenaria
- Published
- 2016-08-31
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| JAK | System, X-Ray, Tomography, Computed |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JAK | System, X-Ray, Tomography, Computed | Radiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04580292766441 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Full-body CT system | An assembly of diagnostic x-ray computed tomography (CT) devices with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other special imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display. |
Regulatory Flags
- DUNS number
- 692969845
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|
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| 00195278932365 | Head Auto Views | GE MEDICAL SYSTEMS, INC. | JAK | 2026-01-26 |
| 04068151048056 | Biograph Trinion.X EP5 CT128 | SIEMENS MEDICAL SOLUTIONS USA, INC. | JAK | 2026-01-09 |
| 04068151048087 | Biograph Trinion.X EP5 CT64 | SIEMENS MEDICAL SOLUTIONS USA, INC. | JAK | 2026-01-09 |
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| 07290018016206 | HealthOST | NANO-X AI LTD | JAK | 2025-12-14 |
| 01935687000038 | CT:VQ | 4DMEDICAL LIMITED | JAK | 2025-12-08 |
| 04056869295541 | SOMATOM X.cite | Siemens Shanghai Medical Equipment Ltd. | JAK | 2025-11-30 |
| 04056869295558 | SOMATOM X.ceed | Siemens Shanghai Medical Equipment Ltd. | JAK | 2025-11-30 |
| 04056869973500 | SOMATOM Pro.Pulse | Siemens Shanghai Medical Equipment Ltd. | JAK | 2025-11-30 |
| 04056869290355 | syngo.CT CaScoring | Siemens Healthcare GmbH | JAK | 2025-11-24 |
| 00198953049174 | Revolution | Hangwei General Electric Medical System Co., Ltd. | JAK | 2025-10-15 |
| 00198953049631 | Revolution | Hangwei GE Medical Systems Co., Ltd. | JAK | 2025-09-09 |
| 00198953061329 | NMCT 860 | G E MEDICAL SYSTEMS ISRAEL LTD. | JAK | 2025-09-09 |
| 00198953061336 | NMCT 850 | G E MEDICAL SYSTEMS ISRAEL LTD. | JAK | 2025-09-09 |
| 00195278943934 | Revolution | Hangwei GE Medical Systems Co., Ltd. | JAK | 2025-08-22 |
| 06971576832033 | uMI | Shanghai United Imaging Healthcare Co., Ltd. | JAK | 2025-08-03 |
| B720BX360ELUNG220 | e-Lung | BRAINOMIX LIMITED | JAK | 2025-07-25 |
| M722C25133CA241430 | ClearRead CT CAC Server | Riverain Technologies, Inc. | JAK | 2025-06-17 |
| M722CC25133CA241430 | ClearRead CT CAC Console | Riverain Technologies, Inc. | JAK | 2025-06-17 |
| M722CD25133CA241430 | ClearRead CT CAC Docker | Riverain Technologies, Inc. | JAK | 2025-06-17 |
| 10810068811510 | Monarch™ Laptop P17 Software v4.1.1 | AURIS HEALTH, INC. | JAK | 2025-06-04 |
| 10810068811527 | Monarch™ Laptop P16 Software v4.1.1 | AURIS HEALTH, INC. | JAK | 2025-06-04 |
| 00884838119253 | Spectral CT System Upgrades | Philips Medical Systems Nederland B.V. | JAK | 2025-05-25 |
| 20884521852195 | superDimension | Covidien LP | JAK | 2025-05-18 |