Encompass 15 Channel Head Coil, 3T— 510(k) K190668
Substantially EquivalentQfix
FDA 510(k) clearance K190668 for Encompass 15 Channel Head Coil, 3T, Substantially Equivalent on 2019-09-09. Applicant: Qfix. Device class: 2.
Clearance details
- Applicant
- Qfix
- Product code
- Code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Avondale, PA, US
Recent devices under product code MOS
view all- K262330 — dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T
- K262294 — dS FootAnkle 16Ch 1.5T +5 more
- K260947 — 0.55T 12Ch Breast Coil
- K252587 — HD 8Ch Wrist Array
- K252876 — GEM Flex Coil 16-L Array, 3.0T Receive Only +2 more
More clearances from Qfix
view all- K230312 — Iris AirShuttle
- K193243 — Alta Multipurpose Device
- K182189 — Encompass SRS Headframe; Encompass MR SRS Headframe
- K171133 — Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories
- K160627 — Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution
Data sourced from openFDA. This site is unofficial and independent of the FDA.