Voxel Dosimetry v1.0— 510(k) K191216
Substantially EquivalentHermes Medical Solutions AB
FDA 510(k) clearance K191216 for Voxel Dosimetry v1.0, Substantially Equivalent on 2019-10-17. Applicant: Hermes Medical Solutions AB. Device class: 2.
Clearance details
- Applicant
- Hermes Medical Solutions AB
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
Recent devices under product code LLZ
view allMore clearances from Hermes Medical Solutions AB
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.