MOSAIQ ONCOLOGY INFORMATION SYSTEM— 510(k) K120067
Substantially EquivalentImpac Medical Systems, Inc.
FDA 510(k) clearance K120067 for MOSAIQ ONCOLOGY INFORMATION SYSTEM, Substantially Equivalent on 2012-02-28. Applicant: Impac Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Impac Medical Systems, 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 Impac Medical Systems, 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 K120067
K-number listed on FDA's recall record- Z-0821-2019 — MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
- Z-0169-2013 — MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images.
- Z-1944-2012 — MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120067.
Data sourced from openFDA. This site is unofficial and independent of the FDA.