SYNGO RT THERAPIST CONNECT— 510(k) K090683
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K090683 for SYNGO RT THERAPIST CONNECT, Substantially Equivalent on 2009-05-08. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Concord, CA, US
Recent devices under product code IYE
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K090683
K-number listed on FDA's recall record- Z-2878-2016 — Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording
- Z-2812-2015 — ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090683.
Data sourced from openFDA. This site is unofficial and independent of the FDA.