Last synced on 20 December 2024 at 11:05 pm

Holder, Radiographic Cassette, Wall-Mounted

Page Type
Product Code
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
892.1880
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1880 Wall-mounted radiographic cassette holder

§ 892.1880 Wall-mounted radiographic cassette holder.

(a) Identification. A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use.

(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 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001]

Holder, Radiographic Cassette, Wall-Mounted

Page Type
Product Code
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
892.1880
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1880 Wall-mounted radiographic cassette holder

§ 892.1880 Wall-mounted radiographic cassette holder.

(a) Identification. A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use.

(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 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001]