Somatom Definition Flash
FDA 510(k) K113342 · Siemens Medical Systems, Inc.
510(k) numberK113342
Submission
- Device name
- Somatom Definition Flash
- Applicant
- Siemens Medical Systems, Inc.
Mavern, PA, US - Received
- November 14, 2011
- Decision date
- December 29, 2011
- 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 |
|---|---|---|
| K133646 | AdmireJAK · Traditional | 06/20/2014SE |
| K130901 | Somatom Definition AS OpenJAK · Traditional | 01/02/2014SE |
| K123540 | Syngo CT Pulmo 3DJAK · Traditional | 08/29/2013SE |
| K123541 | Syngo.Ct Neuro PerfusionJAK · Traditional | 04/02/2013SE |
| K122909 | Syngo Single Source Dual EngeryJAK · Traditional | 12/27/2012SE |
| K122471 | Somatom DefinitionJAK · Special | 09/11/2012SE |
| K120579 | Somatom Definition EdgeJAK · Special | 05/23/2012SE |
| K121072 | Somatom Definition FlashJAK · Special | 05/08/2012SE |
| K052216 | Somatom DefinitionJAK · Traditional | 09/08/2005SE |
| K051602 | Axiom Sireskop SDJAA · Traditional | 07/07/2005SE |
Questions and answers
When was Somatom Definition Flash cleared by the FDA?
Somatom Definition Flash (K113342) received a 510(k) decision of Substantially Equivalent on December 29, 2011, 45 days after the submission was received.
What is the product code of K113342?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.