SOMATOM PERSPECTIVE— 510(k) K113287
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K113287 for SOMATOM PERSPECTIVE, Substantially Equivalent on 2012-05-23. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, 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 Solutions USA, 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 K113287
K-number listed on FDA's recall record- Z-2474-2018 — SOMATOM Perspective (Model 10495568)
- Z-2475-2018 — SOMATOM Perspective 16 (Model 10891666)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113287.
Data sourced from openFDA. This site is unofficial and independent of the FDA.