Senographe Essential, Premium View I (Pvi)
FDA 510(k) K131885 · GE Medical Systems SCS
510(k) numberK131885
Submission
- Device name
- Senographe Essential, Premium View I (Pvi)
- Applicant
- GE Medical Systems SCS
Buc, FR - Received
- June 25, 2013
- Decision date
- September 26, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MUE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254090 | I-View®MUE · Traditional | Hologic, Inc. | 09/02/2026SE |
| K253678 | MAMMOMAT B.brilliant (11372950)MUE · Traditional | Siemens Medical Solutions USA, Inc. | 06/18/2026SE |
| K254092 | Bellalun 2D (VDMS-1000S)MUE · Traditional | Vieworks Co., Ltd. | 05/28/2026SE |
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightMUE · Traditional | GE Medical Systems SCS | 03/24/2026SE |
| K243420 | HestiaMUE · Traditional | Genoray Co., Ltd. | 07/17/2025SE |
| K243849 | 2430TCA with Xmaru WMUE · Special | Rayence Co., Ltd. | 03/12/2025SE |
| K241113 | Vivix-MMUE · Traditional | Vieworks Co., Ltd. | 01/16/2025SE |
| K233539 | MAMMOMAT B.brilliantMUE · Traditional | Siemens Medical Solutions USA, Inc. | 03/27/2024SE |
| K220073 | RMF-2000MUE · Traditional | DRTECH Corporation | 01/26/2023SE |
| K211720 | Planmed Clarity 2D, Planmed Clarify SMUE · Traditional | Planmed OY | 07/18/2022SE |
More from Planmed OY
| 510(k) | Device | Decision |
|---|---|---|
| K253770 | CardIQ SuiteJAK · Traditional | 07/21/2026SE |
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightMUE · Traditional | 03/24/2026SE |
| K251199 | Allia MoveoOWB · Traditional | 12/09/2025SE |
| K243672 | CardIQ SuiteJAK · Traditional | 06/18/2025SE |
| K243651 | VersaViewerLLZ · Traditional | 04/21/2025SE |
| K243446 | 3DXROWB · Traditional | 02/25/2025SE |
| K233731 | CardIQ SuiteJAK · Traditional | 08/01/2024SE |
| K233714 | BreViewLLZ · Traditional | 01/25/2024SE |
| K232344 | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OROWB · Special | 10/11/2023SE |
| K223424 | Spine Auto ViewsJAK · Traditional | 07/13/2023SE |
Questions and answers
When was Senographe Essential, Premium View I (Pvi) cleared by the FDA?
Senographe Essential, Premium View I (Pvi) (K131885) received a 510(k) decision of Substantially Equivalent on September 26, 2013, 93 days after the submission was received.
What is the product code of K131885?
The FDA product code is MUE – Full Field Digital, System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1715.