Hermes Medical Imaging Suite v5.7— 510(k) K171681
Substantially EquivalentHermes Medical Solutions AB
FDA 510(k) clearance K171681 for Hermes Medical Imaging Suite v5.7, Substantially Equivalent on 2017-11-21. Applicant: Hermes Medical Solutions AB. Device class: 2.
Clearance details
- Applicant
- Hermes Medical Solutions AB
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
Recent devices under product code KPS
view allMore clearances from Hermes Medical Solutions AB
view allRecalls naming K171681
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 K171681.
Data sourced from openFDA. This site is unofficial and independent of the FDA.