Product code IZW
- Device name
- Collimator, Automatic, Radiographic
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1610
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K101039 | SHIMADZU COLLIMATOR R-300 | Shimadzu Corp. | 2010-09-20 |
| K093572 | R650 QDASM COLLIMATOR | Omega Medical Imaging, Inc. | 2010-02-03 |
| K090578 | SHIMADZU COLLIMATOR R-30H | Shimadzu Corp. | 2009-11-06 |
| K091517 | RALCO, MODEL R225 ACS | Ralco S.R.L. | 2009-07-14 |
| K083029 | MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR | Ralco S.R.L. | 2008-12-05 |
| K072780 | MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR | Ralco S.R.L. | 2007-11-26 |
| K073124 | COLLIMARE COLLIMATOR FAMILY | Collimare, LLC | 2007-11-16 |
| K050092 | R605 FACS COLLIMETER | Omega Medical Imaging, Inc. | 2005-01-31 |
| K031597 | DUNLEE FORMAT COLLIMATOR FAMILY | Philips Medical Systems North America Co. | 2003-07-21 |
| K990423 | PHILIPS NICOL COLLIMATOR FAMILY | Philips Medical Systems, Inc. | 1999-03-15 |
| K984414 | XRE COLLIMATOR WITH SPECTRAL FILTER | Trex Medical Corp. | 1998-12-30 |
| K960998 | XRE COLLIMATOR | Xre Corp. | 1996-04-03 |
| K951372 | PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE) | Philips Medical Systems, Inc. | 1995-05-04 |
| K920725 | COLLIMATOR F-20 | Shimadzu Medical Systems | 1992-04-16 |
| K920733 | STEREO COLLIMATOR RF-T SERIES | Shimadzu Medical Systems | 1992-04-16 |
| K911127 | COLLIMASTER-90 | Varian Assoc., Inc. | 1991-09-19 |
| K894142 | ULTRANET-S COLLIMATOR | GE Medical Systems | 1989-11-06 |
| K861942 | COLLIMATOR MODEL A280BLE & MODEL A280-BLM | D&R X-Ray Products, Inc. | 1986-07-25 |
| K862340 | SENTEC LASER GUIDE LINE, MODEL SGL-05 | Sentec Corp. | 1986-07-11 |
| K843244 | LIGHT BEAM COLLIMATOR | Dealers X-Ray Co., Inc. | 1984-09-14 |
| K833779 | YTTRO FILTER | Yttro Corp. | 1984-06-05 |
| K810598 | X-RAY COLLIMATING DEVICES | Midmark Corp. | 1981-04-10 |
| K810590 | P.R.M. 80 | T.E.M. Instruments , Ltd. | 1981-04-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06975501940282 | iRay | iRay Imaging Technology (Haining) Limited | 2024-07-20 |
| 08718755002386 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-02-07 |
| 08718755002379 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-02-07 |
| 08718755002249 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-02-07 |
| 08718755002232 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-02-07 |
| 04540217062461 | R-300 | SHIMADZU CORPORATION | 2020-04-03 |
| 04540217062454 | R-300 | SHIMADZU CORPORATION | 2020-04-03 |
| 04540217062447 | R-300 | SHIMADZU CORPORATION | 2020-04-03 |
| 00840682122603 | not applicable | GE MEDICAL SYSTEMS | 2017-09-13 |
| 08718755000429 | Claymount | Varex Imaging Nederland B.V. | 2017-04-14 |
| 00840682118460 | Senographe Pristina | GE MEDICAL SYSTEMS | 2016-11-16 |
| 08718755000375 | Claymount | Varex Imaging Nederland B.V. | 2016-11-07 |
| 08718755000245 | Claymount | Varex Imaging Nederland B.V. | 2016-11-07 |
| 08718755000238 | Claymount | Varex Imaging Nederland B.V. | 2016-11-07 |
| 08718755000221 | Claymount | Varex Imaging Nederland B.V. | 2016-11-07 |
| 08718755000214 | Claymount | Varex Imaging Nederland B.V. | 2016-11-07 |
| 08718755000207 | Claymount | Varex Imaging Nederland B.V. | 2016-11-07 |
| 08718755000153 | Claymount | Varex Imaging Nederland B.V. | 2016-11-07 |
| 08718755000139 | Claymount | Varex Imaging Nederland B.V. | 2016-11-07 |
| 08718755000146 | Claymount | Varex Imaging Nederland B.V. | 2016-11-07 |
| 08718755000122 | Claymount | Varex Imaging Nederland B.V. | 2016-09-12 |
| 08058776050004 | Ralco srl | RALCO SRL | 2016-08-05 |
| 08058776050219 | Ralco srl | RALCO SRL | 2016-08-05 |
| 08058776050226 | Ralco srl | RALCO SRL | 2016-08-05 |
| 08058776050080 | Ralco srl | RALCO SRL | 2016-08-04 |
| 08058776050110 | Ralco srl | RALCO SRL | 2016-08-04 |
| 08058776050127 | Ralco srl | RALCO SRL | 2016-08-04 |
| 08058776050165 | Ralco srl | RALCO SRL | 2016-08-04 |
| 08058776050172 | Ralco srl | RALCO SRL | 2016-08-04 |
| 08058776050196 | Ralco srl | RALCO SRL | 2016-08-04 |