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Table, Radiographic, Tilting

Page Type
Product Code
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
892.1980
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1980 Radiologic table

§ 892.1980 Radiologic table.

(a) Identification. A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.

(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 § 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 63 FR 59231, Nov. 3, 1998]

Table, Radiographic, Tilting

Page Type
Product Code
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
892.1980
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1980 Radiologic table

§ 892.1980 Radiologic table.

(a) Identification. A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.

(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 § 892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 63 FR 59231, Nov. 3, 1998]