FOCAL SIM— 510(k) K013112
Substantially EquivalentComputerized Medical Systems, Inc.
FDA 510(k) clearance K013112 for FOCAL SIM, Substantially Equivalent on 2001-12-05. Applicant: Computerized Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Computerized Medical Systems, 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
- St. Louis, MO, US
Recent devices under product code MUJ
view allMore clearances from Computerized Medical Systems, Inc.
view allRecalls naming K013112
K-number listed on FDA's recall record- Z-1244-2015 — Focal Sim radiation therapy treatment planning system
- Z-2574-2014 — FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
- Z-2002-2012 — Focal SIM Planning of radiation therapy
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K013112.
Data sourced from openFDA. This site is unofficial and independent of the FDA.