CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System— 510(k) K150873
Substantially EquivalentAccuray Incorporated
FDA 510(k) clearance K150873 for CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System, Substantially Equivalent on 2015-07-01. Applicant: Accuray Incorporated. Device class: 2.
Clearance details
- Applicant
- Accuray Incorporated
- 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 Accuray Incorporated
view all- K223159 — Radixact Treatment Delivery System
- K212794 — Accuray Precision Treatment Planning System
- K202412 — ClearRT Helical kVCT for the Radixact Treatment Delivery System
- K182687 — Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System
- K171837 — TomoTherapy Treatment Delivery System with iDMS
Adverse 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 K150873
K-number listed on FDA's recall record- Z-0408-2019 — CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
- Z-1696-2019 — CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System f) 053501-010: CyberKnife Matrix Tier 2 TDS
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150873.
Data sourced from openFDA. This site is unofficial and independent of the FDA.