Ziehm Vision RFD— 510(k) K203428

Clearance details

Applicant

Ziehm Imaging GmbH

Product code

Code JAA

Device class

Class 2

Regulation

21 CFR 892.1650

Advisory panel

Radiology

Date received

2020-11-20

Decision date

2021-03-17

Decision

Substantially Equivalent

Clearance type

Special

Location

Nuremberg, DE

• K253103 — Nexus DRF Digital X-ray Imaging System2026-05-29
• K251650 — Insight Enhanced DRF (EN-1002-01)2025-09-16
• K242488 — Soteria E-View2025-01-06
• K242948 — Adora DRFi (04550010)2024-12-23
• K233380 — TRIDENT Mobile Fluoroscopy System2024-06-26

• K243646 — Ziehm Solo FD2025-03-17
• K243735 — Ziehm Vision FD2025-03-13
• K243303 — Ziehm Vision RFD 3D2025-01-21
• K243328 — Ziehm Vision RFD2025-01-15
• K240099 — Ziehm Vision RFD2024-02-05

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 →