21 CFR 892.1890 — Illuminator, Radiographic-Film

Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1890

Identification

A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
IXCIlluminator, Radiographic-Film118
JAGIlluminator, Radiographic-Film, Explosion-Proof10
Innolitics

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