| Primary Device ID | 00850015518072 |
| NIH Device Record Key | 685391fa-df2b-41dd-9bbc-25ca31c752f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NaviCam Stomach System |
| Version Model Number | Locator AKS-1 |
| Company DUNS | 024972857 |
| Company Name | ANX ROBOTICA CORP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 770-480-2911 |
| tim.thomas@anxrobotics.som |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850015518072 [Primary] |
| QKZ | Magnetically Maneuvered Capsule Endoscopy System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-16 |
| Device Publish Date | 2020-12-08 |
| 00810164590114 - NaviCam Data Recorder | 2026-02-24 |
| 00810164590145 - NaviCam Locator | 2026-02-24 The NaviCam Locator is used to activate the NaviCam SB capsules and may also be used to determine if the capsule is still within |
| 00810164590169 - NaviCam ESView Software | 2026-02-24 The ESView software is used with the NaviCam SB System to analyze the images and create a video for the physician to review afte |
| 00810164590275 - NaviCam ProScan AI Software | 2026-02-24 The NaviCam ProScan AI Software is used with the NaviCam SB System with ESView to identify abnormalities of the small bowel to r |
| 00810164590794 - NaviCam ESView 3.X | 2026-02-24 The NaviCam ESView 3.X software is used with the NaviCam SB System to analyze images to create a video for the physician to revi |
| 00810164590008 - NaviCam SB Capsule | 2026-02-17 NaviCam SB Capsule is a gastrointestinal capsule endoscope used with the NaviCam SB Capsule Endoscope System to visualize the sm |
| 00810164590039 - NaviCam SB Capsule/Tether | 2026-02-17 The NaviCam Capsule/Tether is a NaviCam SB capsule attached to a Tether to allow the physician to view the esophagus before rele |
| 00810164590633 - MotiliCap GI Monitoring System Data Recorder | 2026-02-17 The MotiliCap Data Recorder is used with the MotiliCap GI Monitoring System to receive and store transmitted data from the Motil |