Uroview FD— 510(k) K161019

Clearance details

Applicant

Pausch Medical GmbH

Product code

Code JAA

Device class

Class 2

Regulation

21 CFR 892.1650

Advisory panel

Radiology

Date received

2016-04-12

Decision date

2016-08-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Erlangen, DE

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Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2152-2017 — Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used for urological treatment, planning and diagnostic procedures, including but not limited to.Class II·Terminated·Hans Pausch Rontgengeratebau Gmbh·20170314

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161019.