Definition: To Detect And Display The Shape Of An Inserted Endoscope.
| Device Type ID | 2093 |
| Device Name | Spatial Imaging For Display Of Endoscope Position |
| Physical State | A Control Unit That Communicates With An Endoscope/accessory Probe, A Receiver Dish, And Display Monitor. |
| Technical Method | Measures Electromagnetic Fields From The Endoscope Or An Accessory Within An Endoscope To Determine The Shape Of An Inserted Endoscope, And Displays It On A Monitor. |
| Target Area | Gastrointestinal System |
| Regulation Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PGU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2093 |
| Device | Spatial Imaging For Display Of Endoscope Position |
| Product Code | PGU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
OLYMPUS MEDICAL SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |