MOSAIQ ONCOLOGY INFORMATION SYSTEM— 510(k) K141572
Substantially EquivalentImpac Medical Systems, Inc.
FDA 510(k) clearance K141572 for MOSAIQ ONCOLOGY INFORMATION SYSTEM, Substantially Equivalent on 2014-09-05. 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 K141572
K-number listed on FDA's recall record- 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
- Z-1597-2020 — MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
- 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-0686-2019 — MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
- Z-2917-2018 — MOSAIQ Oncology Information System
- Z-3110-2017 — MOSAIQ Medical Charged-Particle Radiation Therapy System
- Z-0731-2017 — MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed.
- Z-2052-2016 — MOSAIQ Oncology Information System
- Z-0557-2016 — MOSAIQ Oncology Information System 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-0447-2016 — MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
- Z-2063-2015 — MOSAIQ Oncology Information System 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141572.
Data sourced from openFDA. This site is unofficial and independent of the FDA.