Data / Medical devices / Germany / GE Healthcare GmbH
GE Healthcare GmbH: FDA-registered device maker in Munich Bavaria, Germany, 4 510(k) clearances
GE Healthcare GmbH is registered with the FDA (registration 3004497354) in Munich Bavaria, Germany. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated July 2, 2024. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004497354
- Address
- Oskar-Schlemmer-Str. 11, Munich Bavaria, Germany, 80807
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Manufacturer, Specification developer
- First device listed
- January 8, 2018
- Registered through
- 2027
- Brand names listed
- ViewPoint 6, ViewPoint Ultra
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 2, 2024 | K241300 | ViewPoint 6 | LLZ | Substantially Equivalent | Ge Healthcare GmbH | accessdata.fda.gov |
| January 15, 2021 | K203677 | ViewPoint 6 | LLZ | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| January 6, 2020 | K192917 | ViewPoint 6 | LLZ | Substantially Equivalent | Ge Medical Systems Ultrasound And | accessdata.fda.gov |
| January 5, 2018 | K173456 | ViewPoint 6 | LLZ | Substantially Equivalent | Ge Medical Systems Ultrasound and Primary | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 3, 2025 | 98001 | Class II | Ongoing | GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system | GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information. | accessdata.fda.gov |
| August 8, 2024 | 95167 | Class II | Ongoing | ViewPoint; system, imaging processing, radiological | The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint | accessdata.fda.gov |
Compare with other makers
Updated December 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.