Radiology devices; classifications for five medical image management devices; correction--FDA. Final rule; correction.
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 29, 1998 (63 FR 23385). The document classified, along with other devices, the medical image storage device and medical image communications device. These devices were classified into Class I and were exempted from the requirement of premarket notification when they do not use irreversible data compression. The document was published with an incomplete device identification and description of the conditions for exemption from premarket notification. This document corrects those errors.
D016247:Information Storage and Retrieval; D011873:Radiology Information Systems / Q000145:classification*; D019112:Teleradiology / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration