Ict
FDA 510(k) K130224 · Imris, Inc.
510(k) numberK130224
Submission
- Device name
- Ict
- Applicant
- Imris, Inc.
Winnipeg, Mb, CA - Received
- January 29, 2013
- Decision date
- July 18, 2013
- 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 |
|---|---|---|
| K143420 | SYMBIS Surgical SystemHAW · Traditional | 10/30/2015SE |
| K141950 | HFD100 Rocker Arm AccessoryHBL · Special | 09/04/2014SE |
| K133692 | Imri 1.5T and Imri 3T SLNH · Traditional | 02/10/2014SE |
| K123091 | Visius Wireless Coils, 1.5T/ Visius Wireless Coils, 3TMOS · Traditional | 12/27/2012SE |
| K121997 | Imris Oncology PackageLNH · Traditional | 08/10/2012SE |
| K113748 | Imris Mr/X-Ray Head Fixation Device (HFD)HBL · Traditional | 03/23/2012SE |
| K103493 | Head Fiation Device (HFD 100)HBL · Traditional | 03/11/2011SE |
| K103506 | 1.5T Head Coil (HC150), 3T Head Coil (HC300)MOS · Traditional | 02/02/2011SE |
| K101813 | Imrx System V1 and Imrisnv/ImriscardioLNH · Traditional | 10/05/2010SE |
| K091166 | ImrxLNH · Traditional | 09/02/2009SE |
Questions and answers
When was Ict cleared by the FDA?
Ict (K130224) received a 510(k) decision of Substantially Equivalent on July 18, 2013, 170 days after the submission was received.
What is the product code of K130224?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.