Product Code: IXY FDA class 1 21 CFR 892.1880

Holder, Radiographic Cassette, Wall-Mounted

Radiology

A wall-mounted radiographic cassette holder is a fixture mounted to the wall of a radiographic examination room that holds and positions the film cassette at various heights for upright chest and extremity radiography. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IXY, regulated under 21 CFR 892.1880, within the Radiology medical specialty.

510(k)s
21
FEI Numbers
32
Registration Numbers
32
Unique Applicants
18
Years Active
16

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Basic Information

Product Code
IXY
Device Class
FDA class 1
Regulation Number
892.1880
Medical Specialty
Radiology
Review Panel
RA
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 21 510(k) clearances via K numbers.

K Number Device Name
K953402 UNIVERSIX 190
K953336 VRS 3 WALL STAND
K946114 SENSORI-MOTOR RATING SCALE
K946260 NTBS-1417, 1436, TBS-1417
K930249 BC/WT/PF
K930230 RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER
K925934 WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT
K924445 BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY
K922443 VERT-X UNIVERSAL VERTICAL BUCKY STAND
K915667 MODEL H170 PEDIATRIC CHEST X-RAY UNIT
K895034 BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C
K891395 RADKOR BS-10 AND BS-10T
K872132 SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS
K862828 BSX BUCKY-STAND
K860454 BASICAM S COUNTER BALANCE CAMERA
K853756 DYNAMIC CARDIAC PHANTOM 74-347
K851440 RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR
K850125 MULTI-SIZE CASSETTE HOLDER
K810194 WALL CASSETTE HOLDER - TRAC44
K791916 PELICAN BAY KEL-COR CEPHALOMETRIC SYS.
K790742 KS-78 VERTICAL WALL CASSETTE HOLDER

FEI Numbers

This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.