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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR892.2030]
See Related Information on Medical image digitizer. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 892 -- RADIOLOGY DEVICES

Subpart B--Diagnostic Devices

Sec. 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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