Xpert 40 Specimen Radiography System
FDA 510(k) K071233 · Kub Technologies, Inc.
510(k) numberK071233
Submission
- Device name
- Xpert 40 Specimen Radiography System
- Applicant
- Kub Technologies, Inc.
Shelton, CT, US - Received
- May 3, 2007
- Decision date
- June 20, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
More from Cirdan Imaging Limited
| 510(k) | Device | Decision |
|---|---|---|
| K210955 | Kubtec Mozart Supra (XPERT 84) Radiography SystemMWP · Special | 09/20/2021SE |
| K210957 | Kubec Xpert 80 Radiography SystemMWP · Special | 08/31/2021SE |
| K210956 | Kubtec Mozart (XPERT42)MWP · Special | 08/31/2021SE |
| K200756 | Kubtec Mozart SupraMWP · Traditional | 06/12/2020SE |
| K183624 | Kubtec Mozart (Xpert42)MWP · Traditional | 06/20/2019SE |
| K151221 | Kubtec DIGIVIEW 395MQB · Traditional | 06/23/2015SE |
| K141539 | Kubtec X250IZL · Traditional | 10/29/2014SE |
| K103348 | Digiview 250MQB · Traditional | 10/20/2011SE |
| K083510 | Kubtec Xpert 20KPR · Traditional | 01/08/2009SE |
Questions and answers
When was Xpert 40 Specimen Radiography System cleared by the FDA?
Xpert 40 Specimen Radiography System (K071233) received a 510(k) decision of Substantially Equivalent on June 20, 2007, 48 days after the submission was received.
What is the product code of K071233?
The FDA product code is MWP – Cabinet, X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1680.