R-20J
6 catalogue numbers from 563-55050-50, listed by Shimadzu Corp., United States, under Collimator, Manual, Radiographic. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
6catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Shimadzu Corp., United States |
|---|---|
| FDA product code | IZX |
| Device type | Collimator, Manual, Radiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1610 |
| 510(k) | K101036 |
| Record published | 2020-02-21 |
| Record revised | 2025-05-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 563-55050-50 | In distribution | |
| 563-55050-60 | In distribution | |
| 563-55050-23 | In distribution | |
| 563-55050-31 | In distribution | |
| 563-55050-32 | In distribution | |
| 563-55050-26 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Varex Imaging | Varex Imaging Nederland B.V. | 80 |
| Claymount | Varex Imaging Nederland B.V. | 36 |
| Huestis Medical Collimator | Huestis Machine Corp. | 12 |
| Collimare | Collimare, LLC | 7 |
| 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K101036 | 2010-08-26 |
| K042840 | 2004-12-03 |
| K031771 | 2003-08-21 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Shimadzu Medical Systems | 510(k) number | 2011-10-28 | Class II | Nonconforming Material/Component | Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality –(1) Half-value layer (HV | 308 units | 2016-07-26 |
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.