Product code IWY
- Device name
- Holder, Head, Radiographic
- Medical specialty
- Radiology
- Device class
- 1
- Regulation number
- 892.1920
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K925705 | ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM | Denar Corp. | 1992-12-28 |
| K884493 | HEAD HOLDING DEVICE/SLEEP APNEA | X-Ray Systems | 1989-01-12 |
| K884847 | MTD HEDREST | Composites Horizons, Inc. | 1989-01-09 |
| K864527 | DUOCEPH | Gary E. Hall, Dds | 1987-01-07 |
| K850197 | KELLER CEPHALOMETRIC DEVICE | Gary D. Keller | 1985-03-22 |
| K844549 | HEAD-SPINE STABILIZER HSS-1 | Imaging Accessories, Inc. | 1985-03-01 |
| K843340 | PORTA-STAT | Porta-Stat, Inc. | 1984-11-27 |
| K834559 | DELUXE WALL-MOUNTED CEPHALOMETER | Knochen Dental Laboratory | 1984-02-21 |
| K802140 | LEKSELL STEREOTACTIC SYSTEM | Downs Surgical , Ltd. | 1981-02-05 |
| K772313 | X-RAY CO-ORDINATOR | Rinn Corp. | 1978-01-30 |
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| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G242RHIAB9 | Techno-Aide | Techno-Aide, Inc. | 2023-02-13 |
| 10810050244814 | NA | DOMICO MED-DEVICE, LLC | 2021-10-07 |
| 00749756915113 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2021-08-23 |
| 10810050244531 | NA | DOMICO MED-DEVICE, LLC | 2021-07-26 |
| 00810050241625 | NA | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050243339 | SCANCOAT | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050243322 | SCANCOAT | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050243209 | N/A | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050243193 | NA | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050242578 | NA | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050242561 | SCANCOAT | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050242455 | SCANCOAT | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050242448 | NA | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050242165 | NA | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050241960 | Scancoat | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050241724 | NA | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050241717 | SCANCOAT | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050241397 | NA | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050241380 | N/A | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050241274 | NA | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050241069 | NA | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050240987 | N/A | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 10810050243008 | N/A | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 10810050242773 | SCANCOAT | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 10810050242766 | N/A | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 10810050242735 | SCANCOAT | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 10810050242704 | NA | DOMICO MED-DEVICE, LLC | 2020-09-24 |
| 00810050243094 | NA | DOMICO MED-DEVICE, LLC | 2020-08-12 |
| 00810050243100 | Scancoat | DOMICO MED-DEVICE, LLC | 2020-08-12 |
| B790VFPUMP0 | VacFix Pump | TALON | 2019-10-07 |