IXY · Holder, Radiographic Cassette, Wall-Mounted
Radiology · 21 CFR 892.1880 · Class 1
Overview
| Product Code | IXY |
|---|---|
| Device Name | Holder, Radiographic Cassette, Wall-Mounted |
| Regulation | 21 CFR 892.1880 |
| Device Class | Class 1 |
| Review Panel | Radiology |
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.
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 the limitations in § 892.9.
Recent Cleared Devices (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K953402 | UNIVERSIX 190 | Philips Medical Systems (Cleveland), Inc. | Aug 11, 1995 | SESE |
| K953336 | VRS 3 WALL STAND | Philips Medical Systems (Cleveland), Inc. | Aug 11, 1995 | SESE |
| K946114 | SENSORI-MOTOR RATING SCALE | Cmed | Apr 28, 1995 | SESE |
| K946260 | NTBS-1417, 1436, TBS-1417 | Scott Imaging Intl., Inc. | Mar 31, 1995 | SESE |
| K930249 | BC/WT/PF | Tingle X-Ray Products, Inc. | Apr 27, 1993 | SESE |
| K930230 | RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER | American Medical Sales, Inc. | Apr 27, 1993 | SESE |
| K925934 | WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT | Continental X-Ray Corp. | Mar 4, 1993 | SESE |
| K924445 | BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY | Control-X, Inc. | Feb 19, 1993 | SESE |
| K922443 | VERT-X UNIVERSAL VERTICAL BUCKY STAND | Afp Imaging Corp. | Oct 26, 1992 | SESE |
| K915667 | MODEL H170 PEDIATRIC CHEST X-RAY UNIT | H.L. Lyons Co. | Jan 31, 1992 | SESE |
| K895034 | BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C | Yamato Medical Corp. | Nov 15, 1989 | SESE |
| K891395 | RADKOR BS-10 AND BS-10T | Radkor, Inc. | Apr 3, 1989 | SESE |
| K872132 | SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS | Sopha Medical Systems, Inc. | Oct 26, 1987 | SESE |
| K862828 | BSX BUCKY-STAND | Garrels X-Ray Products, Inc. | Aug 1, 1986 | SESE |
| K860454 | BASICAM S COUNTER BALANCE CAMERA | Siemens Gammasonics, Inc. | Feb 21, 1986 | SESE |
| K853756 | DYNAMIC CARDIAC PHANTOM 74-347 | Victoreen, Inc. | Oct 29, 1985 | SESE |
| K851440 | RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR | Summit Industries, Inc. | Jun 5, 1985 | SESE |
| K850125 | MULTI-SIZE CASSETTE HOLDER | Philips Medical Systems (Cleveland), Inc. | Mar 26, 1985 | SESE |
| K810194 | WALL CASSETTE HOLDER - TRAC44 | Philips Medical Systems (Cleveland), Inc. | Feb 25, 1981 | SESE |
| K791916 | PELICAN BAY KEL-COR CEPHALOMETRIC SYS. | Pelican Bay Kel-Cor | Nov 5, 1979 | SESE |
Top Applicants
- Philips Medical Systems (Cleveland), Inc. — 4 clearances
- Yamato Medical Corp. — 1 clearance
- Victoreen, Inc. — 1 clearance
- Tingle X-Ray Products, Inc. — 1 clearance
- Summit Industries, Inc. — 1 clearance
