Philips Incisive CT
FDA 510(k) K212441 · Philips Healthcare (Suzhou) Co., Ltd.
510(k) numberK212441
Submission
- Device name
- Philips Incisive CT
- Applicant
- Philips Healthcare (Suzhou) Co., Ltd.
Suzhou, CN - Received
- August 4, 2021
- Decision date
- April 27, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
| K253450 | BodyTom Elite (NL4000)JAK · Traditional | NeuroLogica Corp., a Samsung Company | 07/28/2026SE |
| K253770 | CardIQ SuiteJAK · Traditional | GE Medical Systems SCS | 07/21/2026SE |
| K253560 | Enhanced Boundary for PCCTJAK · Traditional | Ge Medical Systems, LLC | 06/24/2026SE |
| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | Varian Medical Systems, Inc. | 06/04/2026SE |
| 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 |
| K253686 | True Definition DLJAK · Traditional | Ge Healthcare Japan Corporation | 03/23/2026SE |
| 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 |
More from Siemens Medical Solutions USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | 03/23/2026SE |
| K260519 | Smart Fit TorsoCardiac 1.5TMOS · Special | 03/20/2026SE |
| K242329 | CT Collaboration LiveLLZ · Traditional | 11/18/2024SE |
| K232491 | CT 5300JAK · Traditional | 05/03/2024SE |
| K233600 | Smart Fit Knee 3.0TMOS · Traditional | 02/05/2024SE |
| K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TMOS · Traditional | 09/01/2023SE |
| K223311 | Philips CT 3500JAK · Traditional | 12/22/2022SE |
| K212864 | dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TMOS · Traditional | 12/01/2021SE |
| K211168 | Philips Incisive CT on TrailerJAK · Traditional | 11/22/2021SE |
| K203514 | Precise PositionJAK · Traditional | 06/17/2021SE |
Questions and answers
When was Philips Incisive CT cleared by the FDA?
Philips Incisive CT (K212441) received a 510(k) decision of Substantially Equivalent on April 27, 2022, 266 days after the submission was received.
What is the product code of K212441?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.