Atlas FDA

IYB

40 FDA 510(k) clearances · Product code

45 daysmedian time to decision
148 days90th percentile
40clearances measured

FDA profile

Official device name
Tube Mount, X-Ray, Diagnostic
Device class
Class I (low risk)
Regulation
21 CFR 892.1770
Medical specialty
Radiology
Adverse events (MAUDE)
2001: 7 · 2002: 6 · 2004: 4 · 2005: 3 · 2007: 2 · 2009: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SUPERSTAND 300 (K935123)Wuestec Medical, Inc.1996-03-27
MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 (K946261)Scott Imaging Intl., Inc.1995-02-15
CTS SYSTEM (K941004)Acoma Medical Imaging, Inc.1994-07-29
F/C/W TUBESTAND (K941017)Acoma Medical Imaging, Inc.1994-07-29
MPR-814 (K940442)Xri, Inc.1994-06-09
MODEL ALPHA TS-2 (K935004)Dpa Consulting, Inc.1993-12-13
SUPERSTAND 3000 (K933253)Wuestec Medical, Inc.1993-08-16
BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (K925716)Bennett X-Ray Corp.1992-12-17
SHIMADZU X-RAY TUBE STAND BH-100 SERIES (K925170)Shimadzu Medical Systems1992-12-07
CEILING TUBE SUPPORT CH-30X (K920727)Shimadzu Medical Systems1992-04-16
BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (K914944)Bennett X-Ray Corp.1991-12-02
ER-1000 CATHERIZATION C-ARM SYSTEMS (K914348)Shimadzu Medical Systems1991-11-01
INVENTOR RT/EXPLORER TRAUMA UNIT (K911563)Continental X-Ray Corp.1991-10-23
TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL (K912696)Bennett X-Ray Corp.1991-09-16
PFM-90 CEILING TUBE SUPPORT (K900234)Fischer Imaging Corp.1990-02-26
SHIMADZU X-RAY TUBE STAND FH-31 (K895188)Shimadzu Medical Systems1989-09-22
RADIOGRAPHIC CEILING TUBE SUPPORT CTS15 (K893653)Fischer Imaging Corp.1989-06-23
RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60 (K893652)Fischer Imaging Corp.1989-06-23
LUM VASCULAR PROCEDURE SYSTEM #B5200A (K883664)General Electric Co.1988-11-07
RADKOR SFR-70 (K883864)Radkor, Inc.1988-10-19
RADKOR SFC-21 (K881701)Radkor, Inc.1988-09-08
RADKOR, CST-18 (K882563)Radkor, Inc.1988-07-08
CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX (K880530)Fischer Imaging Corp.1988-03-03
OVERHEAD TUBE MOUNT CASCADE II (K880528)Fischer Imaging Corp.1988-02-29
MODEL C2-5000 OVERHEAD TUBE SUPPORT (K873283)Transworld X-Ray Corp.1987-09-10
COSMOS (K870856)Pausch Corp.1987-03-30
CEILSTAND, MULTISTAND R & S AND THE BUCKYSTAND (K862734)D&R X-Ray Products, Inc.1986-08-01
FCW TUBE STAND (K862827)Garrels X-Ray Products, Inc.1986-08-01
MODEL RS-3 RADIOGRAPHIC STAND (K861995)Medicor USA , Ltd.1986-06-19
TRAUMA STAND (K852952)Xre Corp.1985-09-26
MOUNT TUBE RADIOGRAPHIC (K853682)X-Ray Systems1985-09-19
FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG (K850198)Summit Industries, Inc.1985-05-14
X-RAY TUBESTANDS BUCKY STANDS & VETERINARY X-RAY (K844337)Quality X-Ray Manufacturing, Inc.1985-02-21
COUNTERBALANCED VERTICAL CASSETTE HOLDER (K843928)Poersch Metal Mfg. Co.1984-12-17
FLOOR MOUNTED X-RAY TUBESTAND (K843335)Medicor USA , Ltd.1984-11-27
AP X-RAY TUBE ANGULATION DEVICE (K811970)Philips Medical Systems (Cleveland), Inc.1981-08-13
ARGOSTAT (K811195)Tecnomed, Inc.1981-06-09
X-RAY STAND & OPERATING CHAIR (K803162)Downs Surgical , Ltd.1981-01-28
L/U ARM-VASCULAR (K781571)General Electric Co.1978-11-27
PLURIMAT;RADIOGRAPHIC TUBE MOUNT (K781065)Tecnomed, Inc.1978-07-17

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