FCR 1shot Phantom Plus
1 Shot Phantom Plus is used for quality control of digital Radiography systems.
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 | Fujifilm Corporation, Japan |
|---|---|
| FDA product code | LHO |
| Device type | Instrument, Quality-Assurance, Radiologic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1940 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-06-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 15 to 30 °C; Handling environment humidity 15 to 80 % RH; Storage environment temperature 0 to 45 °C; Storage environment humidity 10 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FCR 1SHOT PHANTOM PLUS MDR E | 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
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.