SCENARIA Phase 3 Whole-body X-ray CT System— 510(k) K150595
Substantially EquivalentHitachi Medical Systems America, Inc.
FDA 510(k) clearance K150595 for SCENARIA Phase 3 Whole-body X-ray CT System, Substantially Equivalent on 2015-10-30. Applicant: Hitachi Medical Systems America, Inc.. Device class: 2.
Clearance details
- Applicant
- Hitachi Medical Systems America, Inc.
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Twinsburg, OH, US
Recent devices under product code JAK
view allMore clearances from Hitachi Medical Systems America, Inc.
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K150595
K-number listed on FDA's recall record- Z-0271-2020 — Hitachi Scenaria Whole-body X-ray CT System
- Z-2839-2018 — Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the SCENARIA can be post processed by the SCENARIA to provide additional information. Post processing capabilities included in the SCENARIA software include CT angiography (CTA), Multiplanar reconstruction (MPR) and volume rendering. Volume datasets acquired by the SCENARIA Phase 3 can be transferred to external devices via a DICOM standard interface. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150595.
Data sourced from openFDA. This site is unofficial and independent of the FDA.