VERIQA— 510(k) K213370
Substantially EquivalentPtw-Freiburg Physikalisch-Technische-Werkstaetten
FDA 510(k) clearance K213370 for VERIQA, Substantially Equivalent on 2022-03-30. Applicant: Ptw-Freiburg Physikalisch-Technische-Werkstaetten. Device class: 2.
Clearance details
- Applicant
- Ptw-Freiburg Physikalisch-Technische-Werkstaetten
- 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
- Freiburg, DE
Recent devices under product code IYE
view allMore clearances from Ptw-Freiburg Physikalisch-Technische-Werkstaetten
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 K213370
K-number listed on FDA's recall record- Z-3174-2026 — Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
- Z-1181-2024 — Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213370.
Data sourced from openFDA. This site is unofficial and independent of the FDA.