Qangio CT
FDA 510(k) K062386 · Medis Medical Imaging Systems BV
510(k) numberK062386
Submission
- Device name
- Qangio CT
- Applicant
- Medis Medical Imaging Systems BV
Leiden, NL - Received
- August 15, 2006
- Decision date
- October 5, 2006
- 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 |
|---|---|---|
| K182611 | Qangio XA 3DQHA · Traditional | 05/30/2019SE |
| K140587 | Mr-Ct VvaLLZ · Traditional | 01/06/2015SE |
| K112807 | X-Ray VvaLLZ · Traditional | 02/27/2012SE |
| K073156 | Qplaque MRLNH · Traditional | 03/04/2008SE |
| K050703 | QbrainLLZ · Traditional | 04/21/2005SE |
| K042383 | Rsa-CmsLLZ · Traditional | 10/20/2004SE |
| K041162 | Ortho-CmsLLZ · Traditional | 07/27/2004SE |
| K040746 | Mra-CmsLLZ · Traditional | 06/08/2004SE |
| K033774 | Ct-MassJAK · Traditional | 03/02/2004SE |
| K023970 | Quantitative Vascular Angiography - CMSIZI · Traditional | 01/24/2003SE |
Questions and answers
When was Qangio CT cleared by the FDA?
Qangio CT (K062386) received a 510(k) decision of Substantially Equivalent on October 5, 2006, 51 days after the submission was received.
What is the product code of K062386?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.