Atlas FDA

IZW

23 FDA 510(k) clearances · Product code

56 daysmedian time to decision
189 days90th percentile
23clearances measured

FDA profile

Official device name
Collimator, Automatic, Radiographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1610
Medical specialty
Radiology
Adverse events (MAUDE)
2000: 1 · 2002: 1 · 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SHIMADZU COLLIMATOR R-300 (K101039)Shimadzu Corp.2010-09-20
R650 QDASM COLLIMATOR (K093572)Omega Medical Imaging, Inc.2010-02-03
SHIMADZU COLLIMATOR R-30H (K090578)Shimadzu Corp.2009-11-06
RALCO, MODEL R225 ACS (K091517)Ralco S.R.L.2009-07-14
MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR (K083029)Ralco S.R.L.2008-12-05
MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR (K072780)Ralco S.R.L.2007-11-26
COLLIMARE COLLIMATOR FAMILY (K073124)Collimare, LLC2007-11-16
R605 FACS COLLIMETER (K050092)Omega Medical Imaging, Inc.2005-01-31
DUNLEE FORMAT COLLIMATOR FAMILY (K031597)Philips Medical Systems North America Co.2003-07-21
PHILIPS NICOL COLLIMATOR FAMILY (K990423)Philips Medical Systems, Inc.1999-03-15
XRE COLLIMATOR WITH SPECTRAL FILTER (K984414)Trex Medical Corp.1998-12-30
XRE COLLIMATOR (K960998)Xre Corp.1996-04-03
PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE) (K951372)Philips Medical Systems, Inc.1995-05-04
COLLIMATOR F-20 (K920725)Shimadzu Medical Systems1992-04-16
STEREO COLLIMATOR RF-T SERIES (K920733)Shimadzu Medical Systems1992-04-16
COLLIMASTER-90 (K911127)Varian Assoc., Inc.1991-09-19
ULTRANET-S COLLIMATOR (K894142)GE Medical Systems1989-11-06
COLLIMATOR MODEL A280BLE & MODEL A280-BLM (K861942)D&R X-Ray Products, Inc.1986-07-25
SENTEC LASER GUIDE LINE, MODEL SGL-05 (K862340)Sentec Corp.1986-07-11
LIGHT BEAM COLLIMATOR (K843244)Dealers X-Ray Co., Inc.1984-09-14
YTTRO FILTER (K833779)Yttro Corp.1984-06-05
X-RAY COLLIMATING DEVICES (K810598)Midmark Corp.1981-04-10
P.R.M. 80 (K810590)T.E.M. Instruments , Ltd.1981-04-10

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