SYNCHRONY RESPIRATORY TRACKING SYSTEM— 510(k) K120233
Substantially EquivalentAccuray Incorporated
FDA 510(k) clearance K120233 for SYNCHRONY RESPIRATORY TRACKING SYSTEM, Substantially Equivalent on 2012-03-09. 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
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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 K120233
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 K120233.
Data sourced from openFDA. This site is unofficial and independent of the FDA.