K Number
K964806Device Name
MD-1835
Manufacturer
Date Cleared
1997-03-04
(95 days)
Product Code
Regulation Number
892.1670AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information
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§ 892.1670 Spot-film device.
(a)
Identification. A spot-film device is an electromechanical component of a fluoroscopic x-ray system that is intended to be used for medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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