VERIQA RT EPID 3D— 510(k) K252258
Substantially EquivalentPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla
FDA 510(k) clearance K252258 for VERIQA RT EPID 3D, Substantially Equivalent on 2026-04-15. Applicant: Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla. Device class: 2.
Summary
VERIQA RT EPID 3D comes from Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla and is filed under product code IYE (Accelerator, Linear, Medical). The record doesn't describe the product beyond its name and that code name.
Class II, 21 CFR 892.5050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Ptw-Freiburg filed from Freiburg, Germany. The record shows 268 calendar days from receipt to decision (July 21, 2025 to April 15, 2026).
Clearance details
- Applicant
- Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla
- Product code
- Product 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
- Freiburg, DE
Recent devices under product code IYE
view allMore clearances from Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.