FDA Product Code IZF: System, X-ray, Tomographic
Leading manufacturers include Nano-X Imaging , Ltd., Pausch Medical GmbH and Adaptix Limited.
FDA 510(k) Cleared System, X-ray, Tomographic Devices (Product Code IZF)
About Product Code IZF - Regulatory Context
510(k) Submission Activity
42 total 510(k) submissions under product code IZF since 1976, with 42 receiving FDA clearance (average review time: 85 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under IZF have taken an average of 107 days to reach a decision - up from 83 days historically. Manufacturers should account for longer review timelines in current project planning.
IZF devices are reviewed by the Radiology panel. Browse all Radiology devices →