Philips Multislice CT System with Low Dose CT Lung Cancer
FDA 510(k) K153444 · Philips Medical Systems (Cleveland), Inc.
510(k) numberK153444
Submission
- Device name
- Philips Multislice CT System with Low Dose CT Lung Cancer
- Applicant
- Philips Medical Systems (Cleveland), Inc.
Cleveland, OH, US - Received
- November 27, 2015
- Decision date
- April 8, 2016
- 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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| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional | Canon Medical Systems Corporation | 05/20/2026SE |
| K253649 | Spectral CT Verida FamilyJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 03/27/2026SE |
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| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 03/23/2026SE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/20/2026SE |
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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 |
| K163711 | IQon Spectral CTJAK · Traditional | 04/05/2017SE |
| K170086 | Pinnacle Radiation Therapy Planning SystemMUJ · Special | 02/09/2017SE |
| K160743 | Philips Ingenuity CTJAK · Traditional | 08/08/2016SE |
| 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 |
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Questions and answers
When was Philips Multislice CT System with Low Dose CT Lung Cancer cleared by the FDA?
Philips Multislice CT System with Low Dose CT Lung Cancer (K153444) received a 510(k) decision of Substantially Equivalent on April 8, 2016, 133 days after the submission was received.
What is the product code of K153444?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.