Green RE 400 Speed
Usabs CAS US Green 400 10X12I.
3manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Guangdong Yuehua Medical Instrument Factory Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 7 |
Record
| Listed by | Agfa Healthcare Inc., Canada |
|---|---|
| FDA product code | IXA |
| Device type | Cassette, Radiographic Film |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1850 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K023020 |
| Record published | 2016-09-01 |
| Record revised | 2019-06-14 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Width 30 to 43 cm; length 18 to 35 cm; width 10 to 12 in; length 8 to 10 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Green RE 400 Speed 8X10 | Width 10 in | In distribution |
| Green RE 400 Speed 10X12 | Length 10 in | In distribution |
| Green RE 400 Speed 18X43 | Width 43 cm | In distribution |
| Green RE 400 Speed 35X43 | Length 35 cm | In distribution |
| Green RE 400 Speed 24X30 | Length 24 cm | In distribution |
| Green RE 400 Speed 30X35 | Width 35 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medical X-ray Cassette with Green 400 Screens | Carestream Health, Inc. | 18 |
| Directview CR Cassette with PQ Screen | Carestream Health, Inc. | 17 |
| dose-map™ | Ashland Specialty Ingredients, G.P. | 17 |
| CR Cassettes for Vita Systems | Carestream Health, Inc. | 12 |
| Curix Ortho Regular | Agfa Healthcare Inc. | 12 |
| Curix Ortho Fast | Agfa Healthcare Inc. | 11 |
| Curix Ortho Medium | Agfa Healthcare Inc. | 11 |
| Select Cassette with Lanex Fast Screens | Carestream Health, Inc. | 10 |
| Select Cassette with Lanex Medium Screens | Carestream Health, Inc. | 8 |
| Select Cassette with Lanex Regular Screens | Carestream Health, Inc. | 7 |
| Huestis Medical Flexi-Holder | Huestis Machine Corp. | 7 |
| Radiographic Film Cassette | JPI Healthcare Co., Ltd. | 5 |
Showing 12 of 31. All products under Cassette, Radiographic Film
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K023020 | 2002-09-26 |
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 |
|---|---|---|---|---|---|---|---|
| Agfa Healthcare Inc. | 510(k) number | 2005-01-26 | Not classified | Other | Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images. | 9055 units | 2006-06-20 |
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.