Pie Medical Equipment B.V.
NetherlandsFDA applicant, unverified
- Devices
- 8
What Pie Medical Equipment B.V. makes
Pie Medical Equipment B.V. manufactures diagnostic ultrasound systems, including the SC1150 CW/PD and SC250/SC480 models, along with specialized transducers such as transvaginal assemblies, endorectal probes, and 7.5 MHz APAS transducers. Their portfolio also includes the CAAS II b-plane imaging option for vascular assessments.
The company’s devices are classified as Class II under FDA regulations and are recorded in the 510(k) premarket notification database. The manufacturer is based in the United States.
Catalogue
SC1150 Cw/Pd Ref K912819
Regimes: 510(k) Registry: 510(k)Diagnostic Ultrasound System Model SC250 Ref K915647
Regimes: 510(k) Registry: 510(k)Diagnostic Ultrasound System Model SC480 Ref K911584
Regimes: 510(k) Registry: 510(k)Transvaginal Transducer Assembly Ref K900838
Regimes: 510(k) Registry: 510(k)Caas Ii Lva Biplane Option Ref K982203
Regimes: 510(k) Registry: 510(k)7.5 Mhz Apas Transducer (Art.nol: 50.04918.1) Ref K911044
Regimes: 510(k) Registry: 510(k)Hemisphere Multiplane Endorectal Probe Ref K911043
Regimes: 510(k) Registry: 510(k)Caas Ii Ref K945540
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pie Medical Equipment B.V. have in the registry?
The registry currently lists 8 devices for Pie Medical Equipment B.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pie Medical Equipment B.V.'s devices?
Among its 8 most recently registered devices, Pie Medical Equipment B.V. has devices listed in FDA 510(k) (8 devices).
What risk classes do Pie Medical Equipment B.V.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Pie Medical Equipment B.V.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pie Medical Equipment B.V. in the registry?
The most recently registered devices listed for Pie Medical Equipment B.V. include SC1150 CW/PD, DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250, DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480 and TRANSVAGINAL TRANSDUCER ASSEMBLY.