FDA device listing
ABUS Single-Use Stabilization Membrane - non Sterile,Invenia ABUS,Invenia ABUS 2.0,Invenia ABUS Premium,Invenia ABUS…
FDA device listing 1844139467 · GE HealthCare Technologies Inc.
Key facts
| Proprietary names | ABUS Single-Use Stabilization Membrane - non Sterile,Invenia ABUS,Invenia ABUS 2.0,Invenia ABUS Premium,Invenia ABUS Prime,Invenia ABUS Review Software,Invenia ABUS Scan Station,Invenia ABUS Workstation |
|---|---|
| Owner/operator | GE HealthCare Technologies Inc. |
| Owner/operator number | 9912004 |
| Premarket submissions | P110006 |
| Product codes | PAA |
| Device names | PAA - Automated Breast Ultrasound |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.PAA |
| Review panels | Radiology |
| Registered establishments | GE MEDICAL SYSTEMS (CHINA) CO., LTD., GE Medical Systems Ultrasound and Primary Care Diagnostics LLC, GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC, GE PARALLEL DESIGN, INC. |
| Establishment registrations | 2032350, 9710602, 3005860720, 3032008018 |
| FEI numbers | 3003309342, 3003513129, 3005860720, 3032008018 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database