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Title 21 Part 892 → Subpart B → §892.2030

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.2030

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B → §892.2030

e-CFR data is current as of October 11, 2019

Title 21Chapter ISubchapter HPart 892Subpart B → §892.2030


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


§892.2030   Medical image digitizer.

(a) Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

(b) Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.).

[63 FR 23387, Apr. 29, 1998]


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