SCENARIA View
FDA 510(k) K190841 · Hitachi Healthcare Americas
510(k) numberK190841
Submission
- Device name
- SCENARIA View
- Applicant
- Hitachi Healthcare Americas
Twinsburg, OH, US - Received
- April 1, 2019
- Decision date
- September 13, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
| K253450 | BodyTom Elite (NL4000)JAK · Traditional | NeuroLogica Corp., a Samsung Company | 07/28/2026SE |
| K253770 | CardIQ SuiteJAK · Traditional | GE Medical Systems SCS | 07/21/2026SE |
| K253560 | Enhanced Boundary for PCCTJAK · Traditional | Ge Medical Systems, LLC | 06/24/2026SE |
| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | Varian Medical Systems, Inc. | 06/04/2026SE |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional | Canon Medical Systems Corporation | 05/20/2026SE |
| K253649 | Spectral CT Verida FamilyJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 03/27/2026SE |
| K253686 | True Definition DLJAK · Traditional | Ge Healthcare Japan Corporation | 03/23/2026SE |
| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 03/23/2026SE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/20/2026SE |
More from Siemens Medical Solutions USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K211406 | OASIS MRI SystemLNH · Traditional | 10/07/2021SE |
| K202422 | Arietta 65IYN · Traditional | 11/04/2020SE |
| K202030 | OASIS MRI SystemLNH · Traditional | 10/21/2020SE |
| K200498 | SCENARIA ViewJAK · Traditional | 07/17/2020SE |
| K192851 | OASIS MRI SystemLNH · Traditional | 02/21/2020SE |
| K191233 | Arietta 750IYN · Traditional | 08/09/2019SE |
| K190248 | Arietta 50IYN · Traditional | 04/02/2019SE |
| K183291 | Supria True64 Whole-Body X-Ray CT SystemJAK · Traditional | 02/01/2019SE |
| K183456 | Aloka Arietta 850IYN · Traditional | 01/28/2019SE |
| K172492 | Optical Topography System ETG-4100DQA · Traditional | 08/17/2018SE |
Questions and answers
When was SCENARIA View cleared by the FDA?
SCENARIA View (K190841) received a 510(k) decision of Substantially Equivalent on September 13, 2019, 165 days after the submission was received.
What is the product code of K190841?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.