MOSAIQ Oncology Information System— 510(k) K183034
Substantially EquivalentElekta, Inc.
FDA 510(k) clearance K183034 for MOSAIQ Oncology Information System, Substantially Equivalent on 2018-12-04. Applicant: Elekta, Inc.. Device class: 2.
Clearance details
- Applicant
- Elekta, Inc.
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code IYE
view allMore clearances from Elekta, Inc.
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
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 K183034
K-number listed on FDA's recall record- Z-2591-2021 — MOSAIQ Oncology Information System
- Z-1783-2021 — Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183034.
Data sourced from openFDA. This site is unofficial and independent of the FDA.