CoreLite
X-ray Specimen Imaging Cabinet
2manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
All of them in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Compai Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Compai Medtech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Cirdan Imaging Limited, United Kingdom |
|---|---|
| FDA product code | MWP |
| Device type | Cabinet, X-Ray System |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Establishment | Manufacturer |
| 510(k) | K193317 |
| Record published | 2020-03-31 |
| Record revised | 2026-06-09 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Timberline MPF Lateral Modular Plate Fixation System | Biomet Spine | 11 |
| Faxitron | Faxitron Bioptics, LLC | 11 |
| Timberline® MPF Lateral Interbody Modular Plate Fixation System | Biomet Spine | 10 |
| Kubtec | Kubtec | 4 |
| Faxitron Path | Hologic, Inc. | 3 |
| Faxitron Core | Hologic, Inc. | 2 |
| TrueView | Compai Healthcare (Suzhou) Co., Ltd. | 2 |
| TrueView | Compai Medtech (Suzhou) Co., Ltd. | 2 |
| Trident HD Specimen Radiography | Hologic, Inc. | 2 |
| Faxitron Core | Faxitron Bioptics, LLC | 1 |
| XPERT84 | Kubtec | 1 |
| Faxitron Wedge | Hologic, Inc. | 1 |
Showing 12 of 25. All products under Cabinet, X-Ray System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213691 | 2021-12-22 |
| K193317 | 2019-12-13 |
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.