uDR 592h, uDR 596i— 510(k) K181413
Substantially EquivalentShanghai United Imaging Healthcare Co., Ltd.
FDA 510(k) clearance K181413 for uDR 592h, uDR 596i, Substantially Equivalent on 2018-06-27. Applicant: Shanghai United Imaging Healthcare Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
- 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
- Shanghai, CN
Recent devices under product code KPR
view allMore clearances from Shanghai United Imaging Healthcare Co., Ltd.
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 K181413
K-number listed on FDA's recall record- Z-1160-2021 — Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.
- Z-2521-2020 — uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk.
- Z-1075-2022 — Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181413.
Data sourced from openFDA. This site is unofficial and independent of the FDA.