Horseshoe Headrest
Horseshoe Headrest HFD100 Assembly, 116341-000
2manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hotry Co., Ltd. | Beijing | Beijing | Manufacturer | 9 |
Record
| Listed by | Imris Imaging, Inc., United States |
|---|---|
| FDA product code | HBM |
| Device type | Headrest, Neurosurgical |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4440 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-10-01 |
| Record revised | 2026-04-28 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Horseshoe Headrest HFD100 Assembly | In distribution | |
| Horseshoe Headrest HFD200 Assembly | In distribution | |
| 116961-000 | In distribution | |
| 116668-000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mayfield® | Integra Lifesciences Corporation | 28 |
| Headrest, Neurosurgical | Steris Corporation | 19 |
| Doro® Adaptor | Black Forest Medical GmbH | 7 |
| SBH | SBH Surgical | 5 |
| Doro® Gel Pad | Black Forest Medical GmbH | 5 |
| Doro® Base Unit | Black Forest Medical GmbH | 5 |
| Aesculap | Aesculap AG | 5 |
| Doro Lucent® iMRI Transfer Collision Indicator | Black Forest Medical GmbH | 5 |
| Fukushima Universal Holding System | Charmant, Inc. | 2 |
| Vertical Post Tilted | Charmant, Inc. | 2 |
| Doro Lucent® Transitional Member | Black Forest Medical GmbH | 2 |
| Doro® Table Adaptor | Black Forest Medical GmbH | 2 |
Showing 12 of 33. All products under Headrest, Neurosurgical
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.