Aquilion Premium
FDA 510(k) K120546 · Toshiba Medical Systems Corporation, Japan
510(k) numberK120546
Submission
- Device name
- Aquilion Premium
- Applicant
- Toshiba Medical Systems Corporation, Japan
Tustin, CA, US - Received
- February 23, 2012
- Decision date
- June 13, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
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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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Questions and answers
When was Aquilion Premium cleared by the FDA?
Aquilion Premium (K120546) received a 510(k) decision of Substantially Equivalent on June 13, 2012, 111 days after the submission was received.
What is the product code of K120546?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.