TomoTherapy Treatment Delivery System with iDMS— 510(k) K171837
Substantially EquivalentAccuray Incorporated
FDA 510(k) clearance K171837 for TomoTherapy Treatment Delivery System with iDMS, Substantially Equivalent on 2017-07-25. 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
- Madison, WI, 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
- K171086 — Accuray Precision Treatment Planning System
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 K171837
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171837.
Data sourced from openFDA. This site is unofficial and independent of the FDA.