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Sign in to claim this brandSANTA BARBARA IMAGING SYSTEMS, INC.
United States·US-MF-000007262
Last updated May 24, 2026
What SANTA BARBARA IMAGING SYSTEMS, INC. makes
Santa Barbara Imaging Systems, Inc. manufactures endoscopic imaging systems, including reusable rigid optical arthroscopes and laparoscopes, endoscopic video cameras, and associated components like video processing units, remote controls, and light source adaptors. Their portfolio also includes single-use arthroscopic access cannulas and reusable instrument trays designed for surgical procedures.
The company’s devices are classified under Class I and Class II regulations, with listings in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Santa Barbara Imaging Systems, Inc. primarily manufacture?
Santa Barbara Imaging Systems, Inc. specializes in endoscopic imaging systems and related components. Their portfolio includes reusable rigid optical arthroscopes and laparoscopes, endoscopic video cameras, video image processing units, remote controls, and light source adaptors. They also produce single-use arthroscopic access cannulas and reusable instrument trays, all designed to support surgical procedures.
Where is Santa Barbara Imaging Systems, Inc. based?
The company is headquartered in the United States. While the exact location isn’t specified, its regulatory listings confirm its operational base within the country.
Which regulatory databases list devices manufactured by Santa Barbara Imaging Systems, Inc.?
Devices from Santa Barbara Imaging Systems, Inc. are listed in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system. These registries help track and verify the devices’ compliance and availability in their respective markets.
How are the devices produced by Santa Barbara Imaging Systems, Inc. classified under medical device regulations?
The company’s devices fall under Class I and Class II classifications. Class I devices generally pose minimal risk and may require fewer regulatory controls, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and scrutiny each device undergoes.
Why are some of Santa Barbara Imaging Systems, Inc.’s devices listed in both eudamed and the FDA’s UDI system?
The presence of devices in both eudamed and the FDA’s UDI system reflects their market reach. The EU’s eudamed database is used for devices placed on the European market, while the FDA’s UDI system tracks devices in the United States. Listing in both indicates the company’s devices are authorized for use in both regulatory jurisdictions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 340 Storke Rd., Goleta, United States
- Website
- sbimagingsystems.com
- —
- —
- [email protected]
- Phone
- 805-770-2110
- PRRC Contact
- James Candy
- EUDAMED SRN
- US-MF-000007262
- FDA FEI Number
- —
- DUNS Number
- 065016344
Catalogue (153)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Trinity | 81-10-1200 | FDA UDI | Class II | Active |
| Pixa | 85-10-4010 | FDA UDI | Class II | Active |
| Zeos | 84-14-1046 | FDA UDI | Class II | Active |
| Omni | 83-10-1200 | FDA UDI | Class II | Active |
| Omni | 83-20-5002 | FDA UDI | Class II | Active |
| Zeos | 84-14-4270 | FDA UDI | Class II | Active |
| Zeos | 84-14-1930 | FDA UDI | Class II | Active |
| Zeos | 84-14-2830 | FDA UDI | Class II | Active |
| Zeos | 84-14-1045 | FDA UDI | Class II | Active |
| Trinty | 81-10-4210 | FDA UDI | Class II | Active |
| Zeos | 84-28-0522 | FDA UDI | Class I | Active |
| Zeos | 84-10-4210 | FDA UDI | Class II | Active |
| Zeos | 84-14-4030 | FDA UDI | Class II | Active |
| Imaging (ZEOS) | 84-10-2120 | FDA UDI | Class II | Active |
| Zeos | 84-14-1900 | FDA UDI | Class II | Active |
| Imaging (ZEOS) | 84-20-5005 | FDA UDI | Class II | Active |
| Zeos | 84-10-5121 | FDA UDI | Class II | Active |
| Zeos | 84-18-1001 | FDA UDI | Class II | Active |
| Omni | 83-10-4120 | FDA UDI | Class II | Active |
| Zeos | 84-14-4100 | FDA UDI | Class II | Active |
| Zeos | 84-10-5001 | FDA UDI | Class II | Active |
| Omni | 83-20-50031 | FDA UDI | Class I | Active |
| Zeos | 84-14-2870 | FDA UDI | Class II | Active |
| Zeos | 84-14-1030 | FDA UDI | Class II | Active |
| Imaging (ZEOS) | 84-10-1000 | FDA UDI | Class II | Active |
| Zeos | 84-10-2330 | FDA UDI | Class II | Active |
| Zeos | 84-10-2410 | FDA UDI | Class II | Active |
| Zeos | 84-14-5503 | FDA UDI | Class II | Active |
| Zeos | 84-14-2000 | FDA UDI | Class II | Active |
| Imaging (ZEOS) | 84-20-5004 | EUDAMEDFDA UDI | Class II | Active |
| Zeos | 84-24-4040 | FDA UDI | Class I | Active |
| Trinity | 81-10-2100 | FDA UDI | Class II | Active |
| Zeos | 84-14-2730 | FDA UDI | Class II | Active |
| Zeos | 84-28-1110 | FDA UDI | Class I | Active |
| Zeos | 84-14-4170 | FDA UDI | Class II | Active |
| Zeos | 84-18-1003 | FDA UDI | Class II | Active |
| Zeos | 84-14-5500 | FDA UDI | Class II | Active |
| Zeos | 84-18-1002 | FDA UDI | Class II | Active |
| Zeos | 84-12-3102 | FDA UDI | Class I | Active |
| Zeos | 84-14-1031 | FDA UDI | Class II | Active |
| Zeos | 84-24-4032 | FDA UDI | Class I | Active |
| Zeos | 84-18-1004 | FDA UDI | Class II | Active |
| Zeos | 84-10-6431 | FDA UDI | Class II | Active |
| Zeos | 84-14-4070 | FDA UDI | Class II | Active |
| 8X-10-6XXX Camera Head | K223116 | FDA 510(k) | Class II | Active |
| 8X-10-XXXX Camera System | K152513 | FDA 510(k) | Class II | Active |
| Omni | 83-10-5120 | EUDAMEDFDA UDI | Class I | Active |
| Omni | 83-10-5001 | EUDAMEDFDA UDI | Class I | Active |
| Pixa | 85-10-5120 | EUDAMEDFDA UDI | Class I | Active |
| Pixa | 85-10-5110 | EUDAMEDFDA UDI | Class I | Active |
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