Syngo.Via RT Image Suite— 510(k) K192065
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K192065 for Syngo.Via RT Image Suite, Substantially Equivalent on 2019-09-18. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hoffman Estates, IL, US
Recent devices under product code MUJ
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allRecalls naming K192065
K-number listed on FDA's recall record- Z-3005-2020 — Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
- Z-2688-2020 — syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192065.
Data sourced from openFDA. This site is unofficial and independent of the FDA.