MEVATRON, M 2 CLASS— 510(k) K882729
Substantially EquivalentSiemens Medical Laboratories, Inc.
FDA 510(k) clearance K882729 for MEVATRON, M 2 CLASS, Substantially Equivalent on 1988-09-19. Applicant: Siemens Medical Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Laboratories, 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
- Walnut Creek, CA, US
Recent devices under product code IYE
view allMore clearances from Siemens Medical Laboratories, 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 K882729
K-number listed on FDA's recall record- Z-1678-2020 — MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
- Z-1679-2020 — ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
- Z-1436-2017 — MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K882729.
Data sourced from openFDA. This site is unofficial and independent of the FDA.