Pie Data Medical BV
NetherlandsFDA applicant, unverified
- Devices
- 5
What Pie Data Medical BV makes
Pie Data Medical BV manufactures ultrasound imaging devices, including the ENTERSCAN for gastrointestinal imaging, the PIE MEDICAL SCANNER 1000 for general diagnostic use, and a multipurpose transducer range for various applications. Their product line also includes the ULTRASOUND LINEAR/SECTOR SCANNER 1100 for flexible imaging needs and the FETAL CARE MONITOR ANTEPARTUM 1500 for prenatal monitoring.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. Their products are based in the US and comply with relevant medical device authorisation requirements.
Catalogue
Enterscan Ref K874081
Regimes: 510(k) Registry: 510(k)Pie Medical Scanner 1000 Ref K870058
Regimes: 510(k) Registry: 510(k)Multipurpose Transducer Range Ref K874192
Regimes: 510(k) Registry: 510(k)Ultrasound Linear/Sector Scanner 1100 Ref K870653
Regimes: 510(k) Registry: 510(k)Fetal Care Monitor Antepartum 1500 Ref K871082
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pie Data Medical BV have in the registry?
The registry currently lists 5 devices for Pie Data Medical BV. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pie Data Medical BV's devices?
Among its 5 most recently registered devices, Pie Data Medical BV has devices listed in FDA 510(k) (5 devices).
What risk classes do Pie Data Medical BV's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Pie Data Medical BV's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pie Data Medical BV in the registry?
The most recently registered devices listed for Pie Data Medical BV include ENTERSCAN, PIE MEDICAL SCANNER 1000, MULTIPURPOSE TRANSDUCER RANGE and ULTRASOUND LINEAR/SECTOR SCANNER 1100.