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Media, Reusable Image

Page Type
Product Code
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
892.1840
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1840 Radiographic film

§ 892.1840 Radiographic film.

(a) Identification. Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.

(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.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001]

Media, Reusable Image

Page Type
Product Code
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
892.1840
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1840 Radiographic film

§ 892.1840 Radiographic film.

(a) Identification. Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.

(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.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001]