Simpleware , Ltd. is one of 463 FDA 510(k) medical device manufacturers from United Kingdom in the dataset, ranked by real submission volume.
Simpleware , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: SCANIP
1
Total
1
Cleared
0
Denied
Simpleware, Ltd. is a 3D image processing software company with a registered facility in Exeter, United Kingdom. The company specializes in medical imaging solutions and computational analysis tools.
Simpleware has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory focus centers on Radiology devices. The cleared device, SCANIP, represents the company's work in medical image segmentation and 3D reconstruction. Simpleware's FDA 510(k) clearance was granted in 2015. The company is currently inactive in the FDA 510(k) clearance process, with no submissions recorded in the past decade.
This profile reflects Simpleware's historical regulatory record. For detailed information on cleared device names, product codes, and specific clearance dates, consult the FDA 510(k) database directly.
FDA 510(k) Regulatory Record - Simpleware , Ltd.
1 devices