Radiology Devices; Classifications for Five Medical Image Management Devices; Correction
fda-device · Food and Drug Administration · Rule · Published 1998-08-24 · Effective 1998-08-24 · 63 FR 44998
Document
Document number
98-22571
Federal Register citation
63 FR 44998
CFR reference
21 CFR 892
Type
Rule
Action
Final rule; correction.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
1998-08-24
Effective date
1998-08-24
HHS docket
Docket No. 96N-0320
Abstract
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.