Product code IZX
- Device name
- Collimator, Manual, 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 |
|---|---|---|---|
| K110856 | RALCO | Ralco S.R.L. | 2011-08-10 |
| K101036 | SHIMADZU COLLIMATOR R-20J | Shimadzu Corp. | 2010-08-26 |
| K042840 | SHIMADZU COLLIMATOR R-20J | Shimadzu Corp. | 2004-12-03 |
| K031771 | SHIMADZU COLLIMATOR R-30H | Shimadzu Corp. | 2003-08-21 |
| K981267 | FACTS MONOBLOCK | Dynarad Corp. | 1998-05-06 |
| K974240 | LIGHTLINE-M | Wuestec Medical, Inc. | 1997-12-22 |
| K972966 | AXT 150M MANUAL COLLIMATOR (AXT 150M) | Applied X-Ray Technologies, Inc. | 1997-08-21 |
| K932134 | RINN UNIVERSAL COLLIMATOR | Rinn Corp. | 1993-07-26 |
| K912180 | MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM | Instrumentarium Imaging, Inc. | 1991-10-21 |
| K900007 | R-100-ET MANUAL COLLIMATOR | Advantech | 1990-02-06 |
| K896486 | R-150-ET COLLIMATOR | Advantech | 1990-01-23 |
| K874687 | COLLI-MATETM MODEL NO. B800 | Summit Industries, Inc. | 1987-12-30 |
| K861941 | COLLIMATOR MODEL A280BLMD & MODEL A280BLMP | D&R X-Ray Products, Inc. | 1986-07-25 |
| K840678 | UXM MODEL 8188 | Universal X-Ray | 1984-03-16 |
| K801168 | COLLIMAX X-RAY COLLIMATOR # R-182 | Ito X-Ray Corp. | 1980-07-08 |
| K780736 | CT 5221 DOSE REDUCING COLLIMATORS | Emi Medical, Inc. | 1978-06-02 |
| K771689 | DIAL X COLLIMATOR MODEL A&B | Bennett X-Ray Corp. | 1977-09-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06975501940459 | iRay | iRay Imaging Technology (Haining) Limited | 2025-07-02 |
| 06975501940428 | iRay | iRay Imaging Technology (Haining) Limited | 2024-12-16 |
| 06975501940411 | iRay | iRay Imaging Technology (Haining) Limited | 2024-12-16 |
| 08718755004069 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-09-23 |
| 08718755004052 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-09-23 |
| 08718755003277 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-04-04 |
| 08718755003260 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-04-04 |
| 08718755003284 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-04-04 |
| 08718755003291 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-04-04 |
| 08718755003307 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-04-04 |
| 08718755003253 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-04-04 |
| 08718755003246 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-04-04 |
| 08718755003239 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-04-04 |
| 08718755003222 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-04-04 |
| 08718755003215 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-04-04 |
| 08718755003314 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-04-04 |
| 08718755003321 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-04-04 |
| 08718755003208 | Varex Imaging | Varex Imaging Nederland B.V. | 2022-04-04 |
| 04540217062416 | R-20J | SHIMADZU CORPORATION | 2020-02-21 |
| 04540217062409 | R-20J | SHIMADZU CORPORATION | 2020-02-21 |
| 04540217059539 | R-20J | SHIMADZU CORPORATION | 2020-02-21 |
| 08800011104023 | DRGEM | DRGEM Corporation | 2018-07-24 |
| 08800011104016 | DRGEM | DRGEM Corporation | 2018-07-24 |
| D0035408531 | RINN® | Dentsply International Inc. | 2017-04-03 |
| 04540217051939 | R-300 | SHIMADZU CORPORATION | 2016-10-03 |
| D6475408531 | RINN® | Dentsply International Inc. | 2016-09-23 |
| 04540217051908 | R-300 | SHIMADZU CORPORATION | 2016-09-16 |
| 08058776050059 | Ralco srl | RALCO SRL | 2016-08-05 |
| 08058776050042 | Ralco srl | RALCO SRL | 2016-08-04 |
| 08058776050035 | Ralco srl | RALCO SRL | 2016-08-04 |