SCENARIA WHOLE-BODY X-RAY CT SYSTEM— 510(k) K101888
Substantially EquivalentHitachi Medical Systems America, Inc.
FDA 510(k) clearance K101888 for SCENARIA WHOLE-BODY X-RAY CT SYSTEM, Substantially Equivalent on 2011-04-08. 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 K101888
K-number listed on FDA's recall record- Z-0271-2020 — Hitachi Scenaria Whole-body X-ray CT System
- Z-2392-2016 — Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
- Z-2037-2012 — Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. 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), Multi-planar reconstruction (MPR) and volume rendering.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101888.
Data sourced from openFDA. This site is unofficial and independent of the FDA.