Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
As solid state device technology continues to progress, solid state x-ray imaging devices will assume an ever-increasing role in medical x-ray systems. This evolution will result in a significant number of premarket (510(k)) submissions for devices that utilize various forms of this technology. This document is intended to provide guidance on the type of data needed by the Center for Devices and Radiological Health (CDRH) to establish the substantial equivalence of an SSXI to a previously cleared conventional radiographic film/screen system, fluoroscopic image intensified imaging system, SSXI or similar device.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-1997-N-0389.