NaviCam SB Capsule
NaviCam SB Capsule is a gastrointestinal capsule endoscope used with the NaviCam SB Capsule Endoscope System to visualize the small bowel.
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Hubei. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ankon Technologies Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 2 |
Record
| Listed by | ANX Robotica Corp., United States |
|---|---|
| FDA product code | NEZ |
| Device type | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1300 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2026-02-09 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CP-US-7001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pillcam | Given Imaging Ltd. | 65 |
| Rapid | Given Imaging Ltd. | 21 |
| MiroCam Capsule Endoscope System | IntroMedic Co., Ltd. | 15 |
| PillCam | Covidien LP | 9 |
| NaviCam Small Bowel Capsule Endoscopy System | Ankon Technologies Co., Ltd. | 5 |
| System, Imaging, Gastrointestinal, Wireless, Capsule | Given Imaging Ltd. | 3 |
| PillCam Genius | Given Imaging Ltd. | 3 |
| AdvanCE | Us Endoscopy | 2 |
| MiroCam Capusle Endoscope System | IntroMedic Co., Ltd. | 2 |
| CapsoCam Plus | CapsoVision, Inc. | 2 |
| CapsoRetrieve | CapsoVision, Inc. | 2 |
| CapsoView | CapsoVision, Inc. | 1 |
Showing 12 of 44. All products under System, Imaging, Gastrointestinal, Wireless, Capsule
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233229 | 2024-01-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.