SOMATOM EMOTION 16— 510(k) K050297
Substantially EquivalentSiemens Medical Solution, Inc. USA
FDA 510(k) clearance K050297 for SOMATOM EMOTION 16, Substantially Equivalent on 2005-03-01. Applicant: Siemens Medical Solution, Inc. USA. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solution, Inc. USA
- 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
- Special
- Location
- Malvern, PA, US
Recent devices under product code JAK
view allMore clearances from Siemens Medical Solution, Inc. USA
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 K050297
K-number listed on FDA's recall record- Z-1452-2018 — SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
- Z-1453-2018 — SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
- Z-1454-2018 — SOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
- Z-1459-2018 — SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
- Z-1301-2016 — Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
- Z-1721-2014 — Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050297.
Data sourced from openFDA. This site is unofficial and independent of the FDA.