Product code MWP
- Device name
- Cabinet, X-Ray System
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1680
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230140 | TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) | Compai Healthcare (Suzhou) Co.,Ltd | 2023-04-24 |
| K230136 | TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) | Compai Healthcare (Suzhou) Co.,Ltd | 2023-04-24 |
| K213691 | Solas OR | Cirdan Imaging, Ltd. | 2021-12-22 |
| K210955 | Kubtec Mozart Supra (XPERT 84) Radiography System | Kub Technologies, Inc. | 2021-09-20 |
| K210957 | Kubec Xpert 80 Radiography System | Kub Technologies, Inc. | 2021-08-31 |
| K210956 | Kubtec Mozart (XPERT42) | Kub Technologies, Inc. | 2021-08-31 |
| K202713 | TrueView 100 Pro | Compai Healthcare (Shenzhen) Co.,Ltd | 2020-11-18 |
| K200756 | Kubtec Mozart Supra | Kub Technologies, Inc. | 2020-06-12 |
| K192939 | Volumetric Specimen Imager | Clarix Imaging | 2019-12-27 |
| K193317 | CoreLite X-Ray Specimen Cabinet | Cirdan Imaging Limited | 2019-12-13 |
| K183624 | Kubtec Mozart (Xpert42) | Kub Technologies, Inc. | 2019-06-20 |
| K183142 | PathVisionXL | Faxitron Bioptics, LLC | 2019-03-14 |
| K182727 | Trident HD Specimen Radiography System | Hologic, Inc. | 2019-01-10 |
| K173309 | Faxitron VisionCT | Faxitron Bioptics, LLC | 2018-05-09 |
| K170786 | Faxitron Bioptics Speciemen Radiography System | Faxitron Bioptics, LLC | 2017-07-18 |
| K153583 | BioVision Plus | Faxitron Bioptics, LLC | 2016-04-01 |
| K122428 | FAXITRON SPECIEN RADIOGRAPHY SYSTEM | Faxitron Bioptics, LLC | 2012-09-25 |
| K111508 | TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 | Hologic, Inc. | 2011-08-19 |
| K091928 | 10 X 10 VISION | Bioptics, Inc. | 2010-06-16 |
| K091558 | BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM | Bioptics, Inc. | 2009-07-17 |
| K082432 | CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM | Bioptics, Inc. | 2008-11-21 |
| K072557 | FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20 | Faxitron X-Ray Corp. | 2007-10-30 |
| K071233 | XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM | Kub Technologies, Inc. | 2007-06-20 |
| K061361 | FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50 | Faxitron X-Ray Corp. | 2006-08-15 |
| K052433 | PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM | Bioptics, Inc. | 2005-10-18 |
| K021113 | MAMMOPATH | Fischer Imaging Corp. | 2002-06-13 |
| K852634 | MICRO-FOCUS 50 CABINET X-RAY | Micro-Focus Imaging., Inc. | 1985-07-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05060508820062 | Solas OR | CIRDAN IMAGING LIMITED | 2026-05-05 |
| 25420045516622 | FAXITRON CORE | Hologic, Inc. | 2023-04-11 |
| 25420045516646 | FAXITRON MAMMOTOME | Hologic, Inc. | 2023-04-11 |
| 05060508820017 | CoreLite | CIRDAN IMAGING LIMITED | 2020-03-31 |
| 00880304828261 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830325 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828278 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828285 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828292 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828308 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828315 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828322 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830233 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830257 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830288 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830295 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304830318 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828247 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828230 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828223 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828209 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828193 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304828186 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304827530 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304827516 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304827509 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304827493 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304827479 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304827462 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |
| 00880304827455 | TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM | BIOMET SPINE LLC | 2016-10-14 |