EXACTRAC VERO— 510(k) K122451
Substantially EquivalentBrainlab AG
FDA 510(k) clearance K122451 for EXACTRAC VERO, Substantially Equivalent on 2012-09-28. Applicant: Brainlab AG. Device class: 2.
Clearance details
- Applicant
- Brainlab AG
- 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
- Feldkirchen, DE
Recent devices under product code IYE
view allMore clearances from Brainlab AG
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 K122451
K-number listed on FDA's recall record- Z-0172-2018 — BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac Vero system uses stereoscopic X-ray or Cone Beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the MHI-TM2000 gantry head to the MHITM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.
- Z-1929-2016 — ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122451.
Data sourced from openFDA. This site is unofficial and independent of the FDA.