Reference Detector (TNC)
2 catalogue numbers from 10460001Z, listed by Sun Nuclear Corporation, United States, under Instrument, Quality-Assurance, Radiologic. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Sun Nuclear Corporation, United States |
|---|---|
| FDA product code | LHO |
| Device type | Instrument, Quality-Assurance, Radiologic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1940 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-12-06 |
| 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, serial number |
| Storage | Storage environment atmospheric pressure 57.2 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Storage environment temperature 10 to 40 °C; Handling environment temperature 15 to 35 °C; Handling environment humidity 20 to 80 % RH; Handling environment atmospheric pressure 57.2 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10460001Z | In distribution | |
| 1046400Z | 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.