SOMATOM DEFINITION— 510(k) K122471
Substantially EquivalentSiemens Medical Systems, Inc.
FDA 510(k) clearance K122471 for SOMATOM DEFINITION, Substantially Equivalent on 2012-09-11. 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
- Special
- 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 K122471
K-number listed on FDA's recall record- Z-1518-2016 — Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
- Z-0907-2014 — Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
- Z-0948-2013 — Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122471.
Data sourced from openFDA. This site is unofficial and independent of the FDA.