CEDARA I-SOFTVIEW— 510(k) K022881
Substantially EquivalentCedara Software Corp.
FDA 510(k) clearance K022881 for CEDARA I-SOFTVIEW, Substantially Equivalent on 2002-10-22. Applicant: Cedara Software Corp.. Device class: 2.
Clearance details
- Applicant
- Cedara Software Corp.
- 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
- Traditional
- Location
- Mississauga Ontario, CA
Recent devices under product code LLZ
view allMore clearances from Cedara Software Corp.
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 K022881
K-number listed on FDA's recall record- Z-2601-2017 — Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Z-0878-2017 — Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022881.
Data sourced from openFDA. This site is unofficial and independent of the FDA.