Aquilion CXL
FDA 510(k) K112989 · Toshiba America Medical Systems, In.C
510(k) numberK112989
Submission
- Device name
- Aquilion CXL
- Applicant
- Toshiba America Medical Systems, In.C
Tustin, CA, US - Received
- October 6, 2011
- Decision date
- April 10, 2012
- 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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| 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 |
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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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| K122613 | Vantage Titan with Helios Gradient Model MRT-1504/USLNH · Traditional | 12/13/2012SE |
| K122842 | Radrex-I, SW V4.00 Model DRAD-3000EMQB · Special | 10/09/2012SE |
| K121076 | Ultraextend FX, Ultrasound Workstation PackageLLZ · Traditional | 10/09/2012SE |
| K122109 | Aquilion One Vision, V4.90JAK · Traditional | 09/21/2012SE |
Questions and answers
When was Aquilion CXL cleared by the FDA?
Aquilion CXL (K112989) received a 510(k) decision of Substantially Equivalent on April 10, 2012, 187 days after the submission was received.
What is the product code of K112989?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.