GammaPod™ Breast Immobilization and Localization System
Elliptical 100-50-23M
3manufacturers in China registered for this device type
42catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
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 | Xcision Medical Systems, LLC, United States |
|---|---|
| FDA product code | IWB |
| Device type | System, Radiation Therapy, Radionuclide |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5750 |
| Establishment | Manufacturer |
| 510(k) | K180571 |
| Record published | 2019-03-21 |
| Record revised | 2026-04-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Total volume 16 to 1680 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Inner Breast Cup | Total Volume 1430 ml | 20 | In distribution |
| Breast Cup Flange | 20 | In distribution | |
| Inner Breast Cup | Total Volume 580 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 940 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 300 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 1110 ml | 20 | In distribution |
| Bolus | Total Volume 49 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 570 ml | 20 | In distribution |
| Outer Breast Cup | In distribution | ||
| Outer Breast Cup | In distribution | ||
| Bolus | Total Volume 33 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 440 ml | 20 | In distribution |
| Breast Cup Flange | 20 | In distribution | |
| Inner Breast Cup | Total Volume 870 ml | 20 | In distribution |
| Bolus | Total Volume 23 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 330 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 1550 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 1680 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 790 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 270 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 610 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 360 ml | 20 | In distribution |
| Suction Pump | In distribution | ||
| Inner Breast Cup | Total Volume 520 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 1320 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 1020 ml | 20 | In distribution |
| Bolus | Total Volume 61 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 860 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 290 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 730 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 480 ml | 20 | In distribution |
| Bolus | Total Volume 16 ml | 20 | In distribution |
| Bolus | Total Volume 91 ml | 20 | In distribution |
| Bolus | Total Volume 63 ml | 20 | In distribution |
| Outer Breast Cup | In distribution | ||
| Bolus | Total Volume 42 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 670 ml | 20 | In distribution |
| Bolus | Total Volume 35 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 1210 ml | 20 | In distribution |
| Breast Cup Flange | 20 | In distribution | |
| Bolus | Total Volume 24 ml | 20 | In distribution |
| Inner Breast Cup | Total Volume 390 ml | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Extend Frame system | Elekta Instrument AB | 23 |
| 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 |
| 15-25 MV Isorad Detector (3m Cable) | Sun Nuclear Corporation | 2 |
| Isorad Detector, 6-12MV (+) 3m | Sun Nuclear Corporation | 2 |
Showing 12 of 33. All products under System, Radiation Therapy, Radionuclide
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180571 | 2018-04-04 |
| K172706 | 2017-12-22 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Xcision Medical Systems, LLC | 510(k) number | 2023-11-30 | Class II | Software design | Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected | 4 units | |
| Xcision Medical Systems, LLC | 510(k) number | 2019-07-03 | Class II | Nonconforming Material/Component | One bolt on the V motor was not fully tightened which caused a drift of.13 degrees in alignment resulting in reduced dose output. | 2 | 2021-07-01 |
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.