syngo.via RT Image Suite— 510(k) K211379
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K211379 for syngo.via RT Image Suite, Substantially Equivalent on 2021-07-30. 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
- Knoxville, TN, US
Recent devices under product code MUJ
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allRecalls naming K211379
K-number listed on FDA's recall record- Z-0994-2022 — syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
- Z-2445-2021 — syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K211379.
Data sourced from openFDA. This site is unofficial and independent of the FDA.