SIMVIEW 3000 CT OPTION— 510(k) K953233
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K953233 for SIMVIEW 3000 CT OPTION, Substantially Equivalent on 1996-11-29. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code KPQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5840
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Concord, CA, US
Recent devices under product code KPQ
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allRecalls naming K953233
K-number listed on FDA's recall record- Z-0235-2015 — Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer.
- Z-0786-2014 — SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de lEsplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT and SIMVIEW NT with IDI is a radiation therapy simulation system.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K953233.
Data sourced from openFDA. This site is unofficial and independent of the FDA.