VeriSoft
Catalogue number VeriSoft software, listed by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH, under Instrument, Quality-Assurance, Radiologic. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Beijing (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Nanjing Jusha Display Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 7 |
Record
| Listed by | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH |
|---|---|
| FDA product code | LHO |
| Device type | Instrument, Quality-Assurance, Radiologic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1940 |
| Premarket notification | Exempt |
| Record published | 2017-04-26 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VeriSoft software | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Quasar | Modus Medical Devices, Inc. | 93 |
| Easy Cube | L A P Gmbh Laser Applikationen | 91 |
| KermaX-plus | IBA Dosimetry GmbH | 74 |
| Easy Slab | L A P Gmbh Laser Applikationen | 68 |
| Instrument, Quality-Assurance, Radiologic | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 45 |
| Diamentor | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 42 |
| Octavius | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 16 |
| RW3 slab phantom | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 13 |
| Vista | Modus Medical Devices, Inc. | 13 |
| Ruby | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 10 |
| MP1 Manual Water Phantom | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 10 |
| Couchfix | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 7 |
Showing 12 of 163. All products under Instrument, Quality-Assurance, Radiologic
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| PTW North America Corporation | UDI-DI | 2021-08-27 | Class II | Software design | When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific conditions. This error can lead to a too-low or too-high measured absolute dose which a | 1 unit | 2024-02-09 |
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.