Summit X-Ray Collimator
Collimator, manual, Radiographic (892-1610)
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
3recalls on this code
Who Else Makes It
All of them in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Fairy Medical Electrics(Jiaxing)Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 3 |
Record
| Listed by | Summit Industries, LLC, United States |
|---|---|
| FDA product code | IZX |
| Device type | Collimator, Manual, Radiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1610 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K874687 |
| Record published | 2016-09-15 |
| Record revised | 2021-04-29 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Special storage condition: Keep dry; Handling environment atmospheric pressure 10 to 40 °C |
| Distribution end date | 2018-09-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D800 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Varex Imaging | Varex Imaging Nederland B.V. | 80 |
| Claymount | Varex Imaging Nederland B.V. | 36 |
| Huestis Medical Collimator | Huestis Machine Corp. | 12 |
| Collimare | Collimare, LLC | 7 |
| R-20J | Shimadzu Corp. | 6 |
| Linear MC 150 | Carestream Health, Inc. | 4 |
| Ralco srl | Ralco SRL | 3 |
| iRay | iRay Imaging Technology (Haining) Limited | 3 |
| R-300 | Shimadzu Corp. | 3 |
| Drgem | Drgem Corporation | 2 |
| Rinn® | Dentsply LLC | 2 |
| Huestis Medical Collilmator | Huestis Machine Corp. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K874687 | 1987-12-30 |
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|---|
| Summit Industries, LLC | 510(k) number | 2007-08-10 | Not classified | Other | The D800 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table. | 3034 for all units | 2010-03-18 |
| Summit Industries, LLC | 510(k) number | 2007-08-10 | Not classified | Other | The E600 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table. | 3034 for all units | 2010-03-18 |
| Summit Industries, LLC | 510(k) number | 2007-08-10 | Not classified | Other | The F100 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table. | 3034 for all units | 2010-03-18 |
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.