FDA device listing
TOMTEC-ARENA
FDA device listing 1181615785 · Philips Medical Systems International BV
Key facts
| Proprietary names | TOMTEC-ARENA |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K201632 |
| Product codes | LLZ, QIH |
| Device names | LLZ - System, Image Processing, Radiological, QIH - Automated Radiological Image Processing Software |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.2050 |
| Review panels | Radiology |
| Registered establishments | Philips Electronics Ltd, Philips Ultrasound LLC, TOMTEC Imaging Systems GMBH |
| Establishment registrations | 3019216, 8043836, 3000126629 |
| FEI numbers | 3019216, 1000185293, 3000126629 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Manufacturer |
| 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