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Title 21 Part 892 → Subpart B → §892.2040

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.2040

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B → §892.2040

e-CFR data is current as of June 19, 2019

Title 21Chapter ISubchapter HPart 892Subpart B → §892.2040


Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices


§892.2040   Medical image hardcopy device.

(a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.

(b) Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

[63 FR 23387, Apr. 29, 1998]