CTxx85 CT Scanner
FDA 510(k) K201231 · Analogic Corporation
510(k) numberK201231
Submission
- Device name
- CTxx85 CT Scanner
- Applicant
- Analogic Corporation
Peabody, MA, US - Received
- May 7, 2020
- Decision date
- February 2, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Siemens Medical Solutions USA, Inc.
| 510(k) | Device | Decision |
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| K182147 | CTXX85JAK · Traditional | 09/07/2018SE |
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| K161342 | Sonic WindowIYO · Special | 06/15/2016SE |
| K140126 | Sonic WindowIYO · Abbreviated | 03/04/2014SE |
| K071430 | Synerad Omni, Models AN6255 and AN6265KPR · Special | 06/21/2007SE |
| K070829 | Synepix 4600 DetectorMQB · Abbreviated | 05/09/2007SE |
| K051903 | Fetalgard Lite-Nibp, Model Fgl-NibpDXN · Traditional | 12/27/2005SE |
| K052447 | Synerad Impact 60, Synerad Impact 72 and Analogic AMS1600JAK · Abbreviated | 09/21/2005SE |
| K050919 | Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P…DSI · Abbreviated | 06/14/2005SE |
| K043025 | Synerad Omni, Digital X-Ray System, Model AN6250KPR · Abbreviated | 11/19/2004SE |
Questions and answers
When was CTxx85 CT Scanner cleared by the FDA?
CTxx85 CT Scanner (K201231) received a 510(k) decision of Substantially Equivalent on February 2, 2021, 271 days after the submission was received.
What is the product code of K201231?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.