FDA device listing
PENTAX Medical Smart Assistant System SAS-M10,PENTAX Medical Smart Assistant System SAS-M10-
FDA device listing 1674760272 · HOYA Corporation PENTAX Division
Key facts
| Proprietary names | PENTAX Medical Smart Assistant System SAS-M10,PENTAX Medical Smart Assistant System SAS-M10- |
|---|---|
| Owner/operator | HOYA Corporation PENTAX Division |
| Owner/operator number | 8030235 |
| Product codes | QNP |
| Device names | QNP - Gastrointesinal Lesion Software Detection System |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1520 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | HOYA Corporation PENTAX Lifecare Division |
| Establishment registrations | 9610877 |
| FEI numbers | 3008185830 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| 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