FDA device listing
NCU-7000 CABLE (OS-A98),NCU-7000 EXTERNAL POSITION SENSOR (OS-A100),NCU-7000 FIELD GENERATOR UNIT (OS-A95),NCU-7000…
FDA device listing 2046468169 · HOYA Corporation PENTAX Division
Key facts
| Proprietary names | NCU-7000 CABLE (OS-A98),NCU-7000 EXTERNAL POSITION SENSOR (OS-A100),NCU-7000 FIELD GENERATOR UNIT (OS-A95),NCU-7000 KEYBOARD (OS-A97),NCU-7000 REMOTE CONTROL UNIT (OS-A99),PENTAX Medical Field Generator Stand (OS-A96-OUS),SCOPEPILOT (NCU-7000),VIDEO PROCESSOR - (EPK-1000-OUS),VIDEO PROCESSOR (EPK-P-OUS),VIDEO PROCESSOR - INTERNATIONAL (EPK-1000-INTL) |
|---|---|
| Owner/operator | HOYA Corporation PENTAX Division |
| Owner/operator number | 8030235 |
| Product codes | FET |
| Device names | FET - Endoscopic Video Imaging System/Component, Gastroenterology-Urology |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | HOYA Corporation PENTAX Lifecare Division |
| Establishment registrations | 9610877, 3003782610 |
| FEI numbers | 3003782610, 3008185830 |
| Establishment operations | Complaint File Establishment, Specification Developer, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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