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Title 21 Part 892 → Subpart B → §892.1640

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.1640

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B → §892.1640

e-CFR data is current as of September 18, 2019

Title 21Chapter ISubchapter HPart 892Subpart B → §892.1640


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


§892.1640   Radiographic film marking system.

(a) Identification. A radiographic film marking system is a device intended for medical purposes to add identification and other information onto radiographic film by means of exposure to visible light.

(b) Classification. Class I (general 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.

[55 FR 48444, Nov. 20, 1990, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38819, July 25, 2001]