Cabinet, X-Ray System
FDA product code MWP · Class II (moderate risk) · 21 CFR 892.1680 · Radiology
27510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230140 | TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)MWP · Traditional | Compai Healthcare (Suzhou) Co.,Ltd | 04/24/2023SE |
| K230136 | TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)MWP · Traditional | Compai Healthcare (Suzhou) Co.,Ltd | 04/24/2023SE |
| K213691 | Solas ORMWP · Traditional | Cirdan Imaging, Ltd. | 12/22/2021SE |
| K210955 | Kubtec Mozart Supra (XPERT 84) Radiography SystemMWP · Special | Kub Technologies, Inc. | 09/20/2021SE |
| K210957 | Kubec Xpert 80 Radiography SystemMWP · Special | Kub Technologies, Inc. | 08/31/2021SE |
| K210956 | Kubtec Mozart (XPERT42)MWP · Special | Kub Technologies, Inc. | 08/31/2021SE |
| K202713 | TrueView 100 ProMWP · Traditional | Compai Healthcare (Shenzhen) Co.,Ltd | 11/18/2020SE |
| K200756 | Kubtec Mozart SupraMWP · Traditional | Kub Technologies, Inc. | 06/12/2020SE |
| K192939 | Volumetric Specimen ImagerMWP · Traditional | Clarix Imaging | 12/27/2019SE |
| K193317 | CoreLite X-Ray Specimen CabinetMWP · Traditional | Cirdan Imaging Limited | 12/13/2019SE |
| K183624 | Kubtec Mozart (Xpert42)MWP · Traditional | Kub Technologies, Inc. | 06/20/2019SE |
| K183142 | PathVisionXLMWP · Traditional | Faxitron Bioptics, LLC | 03/14/2019SE |
| K182727 | Trident HD Specimen Radiography SystemMWP · Traditional | Hologic, Inc. | 01/10/2019SE |
| K173309 | Faxitron VisionCTMWP · Traditional | Faxitron Bioptics, LLC | 05/09/2018SE |
| K170786 | Faxitron Bioptics Speciemen Radiography SystemMWP · Traditional | Faxitron Bioptics, LLC | 07/18/2017SE |
| K153583 | BioVision PlusMWP · Special | Faxitron Bioptics, LLC | 04/01/2016SE |
| K122428 | Faxitron Specien Radiography SystemMWP · Traditional | Faxitron Bioptics, LLC | 09/25/2012SE |
| K111508 | Trident Specimen Radiography System, Model : RC TRI-00001MWP · Traditional | Hologic, Inc. | 08/19/2011SE |
| K091928 | 10 X 10 VisionMWP · Traditional | Bioptics, Inc. | 06/16/2010SE |
| K091558 | Biovision Digital Specimen Radiography SystemMWP · Traditional | Bioptics, Inc. | 07/17/2009SE |
| K082432 | Core Vision Digital Specimen Radiography (DSR) SystemMWP · Traditional | Bioptics, Inc. | 11/21/2008SE |
| K072557 | Faxitron Specimen Radiography System, Model MX-20MWP · Traditional | Faxitron X-Ray Corp. | 10/30/2007SE |
| K071233 | Xpert 40 Specimen Radiography SystemMWP · Traditional | Kub Technologies, Inc. | 06/20/2007SE |
| K061361 | Faxitron Digital Radiography System, Model DX-50MWP · Traditional | Faxitron X-Ray Corp. | 08/15/2006SE |
| K052433 | Pixarray 100 Digital Specimen Radiography (DSR) SystemMWP · Traditional | Bioptics, Inc. | 10/18/2005SE |
| K021113 | MammopathMWP · Traditional | Fischer Imaging Corp. | 06/13/2002SE |
| K852634 | Micro-Focus 50 Cabinet X-RayMWP · Traditional | Micro-Focus Imaging., Inc. | 07/19/1985SE |