IQon Spectral CT
FDA 510(k) K163711 · Philips Medical Systems (Cleveland), Inc.
510(k) numberK163711
Submission
- Device name
- IQon Spectral CT
- Applicant
- Philips Medical Systems (Cleveland), Inc.
Cleveland, OH, US - Received
- December 30, 2016
- Decision date
- April 5, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
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| K253649 | Spectral CT Verida FamilyJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 03/27/2026SE |
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| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/20/2026SE |
More from Siemens Medical Solutions USA, Inc.
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| K171850 | Philips CT Big BoreJAK · Traditional | 11/09/2017SE |
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| K162838 | Philips iCT CT SystemJAK · Traditional | 04/07/2017SE |
| K170086 | Pinnacle Radiation Therapy Planning SystemMUJ · Special | 02/09/2017SE |
| K160743 | Philips Ingenuity CTJAK · Traditional | 08/08/2016SE |
| K153444 | Philips Multislice CT System with Low Dose CT Lung CancerJAK · Traditional | 04/08/2016SE |
| K130992 | PINNACLE3 Radiation Therapy Planning SystemIYE · Traditional | 06/14/2013SE |
| K111336 | Ebw NM 2.0LLZ · Traditional | 05/24/2011SE |
| K111024 | Jetpack 2.0LLZ · Traditional | 04/21/2011SE |
| K092747 | Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolJAK · Traditional | 10/09/2009SE |
Questions and answers
When was IQon Spectral CT cleared by the FDA?
IQon Spectral CT (K163711) received a 510(k) decision of Substantially Equivalent on April 5, 2017, 96 days after the submission was received.
What is the product code of K163711?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.