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Title 21 Part 892 → Subpart B → §892.1670

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.1670

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B → §892.1670

e-CFR data is current as of June 4, 2020

Title 21Chapter ISubchapter HPart 892Subpart B → §892.1670


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


§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.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]