CADSTREAM VERSION 5— 510(k) K092954
Substantially EquivalentConfirma, Inc.
FDA 510(k) clearance K092954 for CADSTREAM VERSION 5, Substantially Equivalent on 2009-11-06. Applicant: Confirma, Inc.. Device class: 2.
Clearance details
- Applicant
- Confirma, Inc.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bellevue, WA, US
Recent devices under product code LLZ
view allMore clearances from Confirma, Inc.
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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 K092954
K-number listed on FDA's recall record- Z-0137-2017 — CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Z-2871-2016 — CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.
- Z-0118-2017 — CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092954.
Data sourced from openFDA. This site is unofficial and independent of the FDA.