Atlas FDA

IZZ

29 FDA 510(k) clearances · Product code

45 daysmedian time to decision
157 days90th percentile
29clearances measured

FDA profile

Official device name
Table, Radiographic, Non-Tilting, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1980
Medical specialty
Radiology
Adverse events (MAUDE)
2002: 1 · 2008: 35 · 2009: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE (K971452)Siemens Medical Solutions USA, Inc.1997-05-14
MED-TRON SPECT IMAGING TABLE (K952701)Med-Tron Products, Inc.1995-07-06
CATHETERIZATION TABLE KS-60 (K951315)Shimadzu Medical Systems1995-05-11
ANGIOREX CAT-350B (K951053)Toshiba America Medical Systems, In.C1995-04-06
RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE (K943926)Philips Medical Systems (Cleveland), Inc.1994-11-28
ALPHA (K930273)Raymax Medical Corp.1993-07-13
B-4 FOUR-WAY RADIOGRAPHIC TABLE (K924444)Control-X, Inc.1993-02-05
SHIMADZU RADIOGRAPHIC TABLE BK-100 (K925174)Shimadzu Medical Systems1992-11-27
DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004 (K921501)Biodan Medical Systems, Ltd.1992-05-15
CATHERIZATION KS-50 (K920732)Shimadzu Medical Systems1992-04-16
CAT-250B (K915413)Toshiba America Medical Systems, In.C1991-12-19
CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111 (K912516)Continental X-Ray Corp.1991-11-19
CLASSIC 4-WAY ELEVATING TABLE (K912474)Continental X-Ray Corp.1991-09-16
MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE (K903921)Imt America, Inc.1990-12-04
EXT-600 TABLE, RADIOGRAPHIC, ELEVATING (K896665)Rms Div.1990-01-22
GX-ELEVATOR (K894188)Gendex Corp.1989-10-03
EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM (K893452)Warner-Lambert Co.1989-06-22
HUGH YOUNG II UROLOGICAL TABLE (K891403)Mallinckrodt Group, Inc.1989-06-22
CXC FFT-1 NON-TILT STAT RADIO XRAY TAB 4 WA FL TAB (K893129)Continental X-Ray Corp.1989-06-01
COMPAX MODEL 40, 400, 400T (K884930)General Electric Co.1988-12-22
TANGENT II (K883974)Fischer Imaging Corp.1988-10-20
RADIOGRAPHIC TABLES MODELS A71OS-T,A71OT-T,A71OB-T (K861940)D&R X-Ray Products, Inc.1986-05-29
PROTECTA COAT SPONGES (K840156)Alimed, Inc.1984-03-23
SPECTRUM X-RAY CORP (K834494)Spectrum X-Ray Corp.1984-02-21
VRT TABLE (K827928)General Electric Co.1982-09-29
HORIZONTAL RADIOGRAPHIC 4/WAY FLOATING (K792169)Bennett X-Ray Corp.1979-12-10
RX PEDESTAL TABLE (K772283)General Electric Co.1977-12-15
X-RAY REMOTE CONTROL TABLE (K771601)Toshiba Medical Systems1977-09-20
RADIAL TRAVEL SPEC. PROCEDURES TABLE (K761339)Xre Corp.1977-01-05

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Every clearance here is in the API, with alerts when new ones post.