Husetis Medical Flexi-Holder
Flexi-Holder GE W/Artic 26" Arm, Huestis Part# FH410-GE
3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Huestis Machine Corp., United States |
|---|---|
| FDA product code | IXA |
| Device type | Cassette, Radiographic Film |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1850 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K792721 |
| Record published | 2016-11-01 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date |
| Distribution end date | 2016-12-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FH410-GE | Withdrawn |
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 |
| Green RE 400 Speed | Agfa Healthcare Inc. | 6 |
Showing 12 of 31. All products under Cassette, Radiographic Film
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K792721 | 1980-02-19 |
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.