ManoScan
ManoScan (TM) Software Kit Acquisition Software
1manufacturer
60catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ankon Medical Technologies (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
Record
| Listed by | Given Imaging Ltd., Israel |
|---|---|
| FDA product code | FFX |
| Device type | System, Gastrointestinal Motility (Electrical) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1725 |
| Establishment | Manufacturer |
| 510(k) | K151086 |
| Record published | 2016-09-24 |
| Record revised | 2024-11-15 (version 17) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 65 °C; Handling environment temperature 10 to 35 °C |
| Distribution end date | 2016-09-24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 3920 | In distribution | ||
| FGS-8038 | Power Force,120/240,Volt;Frequency,50/60,HZ,Current,5.2/2.6,AMP; | In distribution | |
| 3886 | In distribution | ||
| 800028 | In distribution | ||
| MSS-2599 | 10 | In distribution | |
| MSS-2637 | 10 | In distribution | |
| RFG-3890 | In distribution | ||
| RFG-1286-EAN | In distribution | ||
| 4604 | In distribution | ||
| FGS-0715 | In distribution | ||
| FGS-0684 | In distribution | ||
| FGS-8007 | In distribution | ||
| FGS-0580 | In distribution | ||
| RFG-8001 | In distribution | ||
| RFG-2192 | In distribution | ||
| RFG-1286 | In distribution | ||
| 3890 | In distribution | ||
| FGS-8039 | In distribution | ||
| FGS-0570 | In distribution | ||
| 1286 | In distribution | ||
| 4279- | In distribution | ||
| 3887 | In distribution | ||
| 2195 | In distribution | ||
| MSS-4360 | 20 | In distribution | |
| RFG-3885 | In distribution | ||
| RFG-4189 | In distribution | ||
| 800027 | In distribution | ||
| MSS-3598 | 10 | In distribution | |
| 800000 | In distribution | ||
| 800024 | In distribution | ||
| 800026 | In distribution | ||
| FGS-4374 | In distribution | ||
| RFG-3887 | In distribution | ||
| FGS-8001 | In distribution | ||
| MSS-2155 | 20 | In distribution | |
| 150110 | In distribution | ||
| MSS-3599 | 10 | In distribution | |
| 4439 | In distribution | ||
| RFG-3890-EAN | In distribution | ||
| FGS-8020 | In distribution | ||
| FGS-0571 | In distribution | ||
| FGS-0559 | In distribution | ||
| FGS-0649 | In distribution | ||
| FGS-0582 | In distribution | ||
| RFG-2195 | In distribution | ||
| FGS-0573 | In distribution | ||
| 4189 | In distribution | ||
| RFB-4374 | In distribution | ||
| RFG-8000-15 | In distribution | ||
| 3885 | In distribution | ||
| 800015 | In distribution | ||
| FGS-8045 | In distribution | ||
| RFG-3886 | In distribution | ||
| RFG-3920 | In distribution | ||
| 2192 | In distribution | ||
| MSS-4581-3D | 10 | In distribution | |
| FGS-0651 | In distribution | ||
| 800029 | In distribution | ||
| FGS-8046 | In distribution | ||
| 800002 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mui Scientific | H&A Mui Enterprises, Inc. | 771 |
| UniTip High Resolution Catheter | Unisensor AG | 183 |
| UniTip Catheter | Unisensor AG | 100 |
| Diversatek Healthcare | Diversatek Healthcare Inc | 27 |
| inSIGHT Ultima | Diversatek Healthcare Inc | 19 |
| Endoflip | Covidien LP | 17 |
| Sitzmarks Radiopaque Markers | Konsyl Pharmaceuticals, Inc. | 14 |
| Zvu® | Diversatek Healthcare Inc | 11 |
| Distender II Barostat | G & J Electronics, Inc. | 9 |
| PriZm | Diversatek Healthcare Inc | 8 |
| ManoView | Given Imaging Ltd. | 6 |
| System, Gastrointestinal Motility (Electrical) | Given Imaging Ltd. | 6 |
Showing 12 of 107. All products under System, Gastrointestinal Motility (Electrical)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151086 | 2016-04-28 |
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.