YSIO X.pree— 510(k) K201670
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K201670 for YSIO X.pree, Substantially Equivalent on 2020-10-21. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code KPR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code KPR
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
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 K201670
K-number listed on FDA's recall record- Z-0730-2022 — YSIO X.Pree
- Z-1346-2021 — Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201670.
Data sourced from openFDA. This site is unofficial and independent of the FDA.