IZZ · Table, Radiographic, Non-Tilting, Powered
Radiology · 21 CFR 892.1980 · Class 2
Overview
| Product Code | IZZ |
|---|---|
| Device Name | Table, Radiographic, Non-Tilting, Powered |
| Regulation | 21 CFR 892.1980 |
| Device Class | Class 2 |
| Review Panel | Radiology |
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.
Classification Rationale
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.
Special Controls
*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.
Recent Cleared Devices (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K971452 | MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE | Siemens Medical Solutions USA, Inc. | May 14, 1997 | SESE |
| K952701 | MED-TRON SPECT IMAGING TABLE | Med-Tron Products, Inc. | Jul 6, 1995 | SESE |
| K951315 | CATHETERIZATION TABLE KS-60 | Shimadzu Medical Systems | May 11, 1995 | SESE |
| K951053 | ANGIOREX CAT-350B | Toshiba America Medical Systems, In.C | Apr 6, 1995 | SESE |
| K943926 | RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE | Philips Medical Systems (Cleveland), Inc. | Nov 28, 1994 | SESE |
| K930273 | ALPHA | Raymax Medical Corp. | Jul 13, 1993 | SESE |
| K924444 | B-4 FOUR-WAY RADIOGRAPHIC TABLE | Control-X, Inc. | Feb 5, 1993 | SESE |
| K925174 | SHIMADZU RADIOGRAPHIC TABLE BK-100 | Shimadzu Medical Systems | Nov 27, 1992 | SESE |
| K921501 | DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004 | Biodan Medical Systems, Ltd. | May 15, 1992 | SESE |
| K920732 | CATHERIZATION KS-50 | Shimadzu Medical Systems | Apr 16, 1992 | SESE |
| K915413 | CAT-250B | Toshiba America Medical Systems, In.C | Dec 19, 1991 | SESE |
| K912516 | CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111 | Continental X-Ray Corp. | Nov 19, 1991 | SESE |
| K912474 | CLASSIC 4-WAY ELEVATING TABLE | Continental X-Ray Corp. | Sep 16, 1991 | SESE |
| K903921 | MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE | Imt America, Inc. | Dec 4, 1990 | SESE |
| K896665 | EXT-600 TABLE, RADIOGRAPHIC, ELEVATING | Rms Div. | Jan 22, 1990 | SESE |
| K894188 | GX-ELEVATOR | Gendex Corp. | Oct 3, 1989 | SESE |
| K893452 | EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM | Warner-Lambert Co. | Jun 22, 1989 | SESE |
| K891403 | HUGH YOUNG II UROLOGICAL TABLE | Mallinckrodt Group, Inc. | Jun 22, 1989 | SESE |
| K893129 | CXC FFT-1 NON-TILT STAT RADIO XRAY TAB 4 WA FL TAB | Continental X-Ray Corp. | Jun 1, 1989 | SESE |
| K884930 | COMPAX MODEL 40, 400, 400T | General Electric Co. | Dec 22, 1988 | SESE |
Top Applicants
- Shimadzu Medical Systems — 3 clearances
- General Electric Co. — 3 clearances
- Continental X-Ray Corp. — 3 clearances
- Toshiba America Medical Systems, In.C — 2 clearances
- Xre Corp. — 1 clearance
