SOMATOM SPIRIT— 510(k) K042328
Substantially EquivalentSiemens Medical Systems, Inc.
FDA 510(k) clearance K042328 for SOMATOM SPIRIT, Substantially Equivalent on 2004-09-14. Applicant: Siemens Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Systems, 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
- Mavern, PA, US
Recent devices under product code JAK
view allMore clearances from Siemens Medical Systems, 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 K042328
K-number listed on FDA's recall record- Z-1451-2018 — SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
- 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 K042328.
Data sourced from openFDA. This site is unofficial and independent of the FDA.