15-25 MV Isorad Detector (3m Cable)
2 catalogue numbers from 11640003Z, listed by Sun Nuclear Corporation, United States, under System, Radiation Therapy, Radionuclide. 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 Shaanxi (1), Guangdong (1), Hubei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| OUR United Corporation | Xian | Shaanxi | Contract manufacturer | 2 |
| Masep Medical Science & Technology DEVELOPMENT(SHENZHEN)Co. | Shenzhen | Guangdong | Manufacturer | 2 |
| OUR SMD Medical (Wuhan) Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 1 |
Record
| Listed by | Sun Nuclear Corporation, United States |
|---|---|
| FDA product code | IWB |
| Device type | System, Radiation Therapy, Radionuclide |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5750 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K912250 |
| Record published | 2017-01-14 |
| Record revised | 2019-06-18 (version 5) |
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 temperature -30 to 50 °C; Storage environment humidity 10 to 90 % RH; Special storage condition: After cleaning, allow the detector, cable and connector to dry thoroughly, and then place in the storage case along with; Special storage condition: Store in an indoor, protected environment where the detector will not be irradiated by the direct beam and where scatter; Special storage condition: When shipping a detector, always pack in a shipping container designed for fragile objects. |
| Distribution end date | 2019-06-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11640003Z | Withdrawn | |
| 11640002Z | Withdrawn |
Same Product Code
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| GammaPod™ Breast Immobilization and Localization System | Xcision Medical Systems, LLC | 42 |
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| Clarity® | Elekta Solutions AB | 11 |
| Leksell Gamma Knife Icon | Elekta Instrument AB | 9 |
| Leksell Gamma Knife Perfexion/Icon | Elekta Instrument AB | 9 |
| Leksell Gamma Knife Perfexion/Icon | Elekta Solutions AB | 5 |
| Leksell Gamma Knife Icon | Elekta Solutions AB | 4 |
| GammaBeam | Best Theratronics Ltd. | 2 |
| Leksell Gamma Knife C 4 4C | Elekta Instrument AB | 2 |
| Isorad Detector, 15-25MV (-) 3m | Sun Nuclear Corporation | 2 |
| Leksell GammaPlan | Elekta Solutions AB | 2 |
| Isorad Detector, 6-12MV (+) 3m | Sun Nuclear Corporation | 2 |
Showing 12 of 33. All products under System, Radiation Therapy, Radionuclide
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.