Varex Imaging
x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(Collimator) This is a device out of the Optica 10 series
2manufacturers in China registered for this device type
80catalogue numbers in this listing
Who Else Makes It
All of them in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Fairy Medical Electrics(Jiaxing)Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 3 |
Record
| Listed by | Varex Imaging Nederland B.V., Netherlands |
|---|---|
| FDA product code | IZX |
| Device type | Collimator, Manual, Radiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1610 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-05-18 |
| Record revised | 2025-05-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-05-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OPTICA10-01-017-001-OEM | In distribution | |
| OPTICA10-00-065-001-OEM | Withdrawn | |
| OPTICA10-00-006-001-OEM | Withdrawn | |
| OPTICA20-00-005-001-EU1 | Withdrawn | |
| OPTICA10-00-016-001-OEM | Withdrawn | |
| OPTICA20-00-001-001-EU1 | Withdrawn | |
| OPTICA20-00-003-001-OEM | Withdrawn | |
| OPTICA10-00-064-001-OEM | Withdrawn | |
| OPTICA10-00-042-001-OEM | Withdrawn | |
| OPTICA10-01-042-001-OEM | Withdrawn | |
| OPTICA10-00-004-001-SAMPLE | Withdrawn | |
| OPTICA10-00-013-001-SAMPLE | Withdrawn | |
| OPTICA10-00-009-001-OEM | Withdrawn | |
| OPTICA20-00-007-001-OEM | Withdrawn | |
| OPTICA10-00-000-001-OEM | Withdrawn | |
| OPTICA20-00-029-001-OEM | Withdrawn | |
| OPTICA20-00-000-001-OEM | Withdrawn | |
| OPTICA20-00-001-003-OEM | Withdrawn | |
| OPTICA10-00-010-001-OEM | Withdrawn | |
| OPTICA10-01-014-001-OEM | Withdrawn | |
| OPTICA10-01-010-001-OEM | Withdrawn | |
| OPTICA10-01-022-001-OEM | Withdrawn | |
| OPTICA20-00-006-001-OEM | Withdrawn | |
| OPTICA10-01-018-001-OEM | Withdrawn | |
| OPTICA10-00-007-001-OEM | Withdrawn | |
| OPTICA10-01-001-001-OEM | Withdrawn | |
| OPTICA10-01-000-001-OEM | Withdrawn | |
| OPTICA20-00-000-001-EU1 | Withdrawn | |
| OPTICA10-01-004-001-OEM | Withdrawn | |
| OPTICA10-01-003-001-OEM | Withdrawn | |
| OPTICA10-00-011-001-OEM | Withdrawn | |
| OPTICA10-00-022-001-OEM | Withdrawn | |
| OPTICA10-00-008-001-OEM | Withdrawn | |
| OPTICA20-00-006-001-EU1 | Withdrawn | |
| OPTICA10-01-009-001-OEM | Withdrawn | |
| OPTICA10-00-005-001-OEM | Withdrawn | |
| OPTICA20-00-027-001-OEM | Withdrawn | |
| OPTICA10-01-015-001-OEM | Withdrawn | |
| OPTICA20-00-016-001-OEM | Withdrawn | |
| OPTICA10-00-004-005-OEM | Withdrawn | |
| OPTICA10-00-017-001-OEM | Withdrawn | |
| OPTICA10-01-002-001-OEM | Withdrawn | |
| OPTICA20-00-005-001-OEM | Withdrawn | |
| OPTICA20-00-001-001-OEM | Withdrawn | |
| OPTICA10-01-016-001-OEM | Withdrawn | |
| OPTICA20-00-029-001-OEM | Withdrawn | |
| OPTICA10-00-004-001-OEM | Withdrawn | |
| OPTICA10-00-013-001-OEM | Withdrawn | |
| OPTICA10-00-001-005-OEM | Withdrawn | |
| OPTICA20-00-002-001-EU1 | Withdrawn | |
| OPTICA10-01-013-001-OEM | Withdrawn | |
| OPTICA10-01-065-001-OEM | Withdrawn | |
| OPTICA10-01-012-001-OEM | Withdrawn | |
| OPTICA20-00-007-001-EU1 | Withdrawn | |
| OPTICA10-00-019-001-SAMPLE | Withdrawn | |
| OPTICA10-00-018-001-OEM | Withdrawn | |
| OPTICA10-00-015-001-OEM | Withdrawn | |
| OPTICA10-00-003-001-OEM | Withdrawn | |
| OPTICA10-00-014-001-OEM | Withdrawn | |
| OPTICA10-00-001-001-OEM | Withdrawn | |
| OPTICA10-00-012-001-OEM | Withdrawn | |
| OPTICA20-00-004-001-EU1 | Withdrawn | |
| OPTICA10-01-005-001-OEM | Withdrawn | |
| OPTICA20-00-001-004-OEM | Withdrawn | |
| OPTICA10-00-010-001-SAMPLE | Withdrawn | |
| OPTICA10-00-022-001-OEM-SAMPLE | Withdrawn | |
| OPTICA20-00-031-001-OEM | Withdrawn | |
| OPTICA10-01-006-001-OEM | Withdrawn | |
| OPTICA20-00-003-003-OEM | Withdrawn | |
| OPTICA10-01-008-001-OEM | Withdrawn | |
| OPTICA10-01-011-001-OEM | Withdrawn | |
| OPTICA10-01-064-001-OEM | Withdrawn | |
| OPTICA20-00-000-003-OEM | Withdrawn | |
| OPTICA10-01-007-001-OEM | Withdrawn | |
| OPTICA20-00-003-001-EU1 | Withdrawn | |
| OPTICA20-00-002-001-OEM | Withdrawn | |
| OPTICA10-01-019-001-OEM | Withdrawn | |
| OPTICA20-00-004-001-OEM | Withdrawn | |
| OPTICA10-00-002-001-OEM | Withdrawn | |
| OPTICA10-00-019-001-OEM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Claymount | Varex Imaging Nederland B.V. | 36 |
| Huestis Medical Collimator | Huestis Machine Corp. | 12 |
| Collimare | Collimare, LLC | 7 |
| R-20J | Shimadzu Corp. | 6 |
| Linear MC 150 | Carestream Health, Inc. | 4 |
| Ralco srl | Ralco SRL | 3 |
| iRay | iRay Imaging Technology (Haining) Limited | 3 |
| R-300 | Shimadzu Corp. | 3 |
| Drgem | Drgem Corporation | 2 |
| Rinn® | Dentsply LLC | 2 |
| Huestis Medical Collilmator | Huestis Machine Corp. | 1 |
| Summit X-ray Collimator | Summit Industries, LLC | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.