Phot-X IIs Model 505
PHOT-X IIs Model 505 is a dental X-ray source used with an intraoral film or image receptor to produce images of teeth. The X-ray source remains outside the mouth while the receptor records…
PHOT-X IIs Model 505 is a dental X-ray source used with an intraoral film or image receptor to produce images of teeth. The X-ray source remains outside the mouth while the receptor records the exposure inside.
The unit comprises a tubehead, control box and supporting structure. It uses constant-potential X-ray generation, with selectable tube settings of 60 or 70 kV and 3 or 6 mA.
Listed Item
PHOT-X IIS 505 WK with 20″Arm LCD Subcontroller
Exposure Controls
Exposure time is selectable from 0.01 to 2.0 seconds in multiple steps. The tubehead has a 0.4 mm focal spot, and the support positions the source for the dental projection. The listed configuration includes an arm and LCD subcontroller within the Model 505 family.
Who Else Makes It
Concentrated in Guangxi (2), Guangdong (2), Zhejiang (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Guilin Refine Medical Instrument Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 7 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Orich Medical Equipment (Tianjin) Co., Ltd. | Tianjin | Tianjin | Manufacturer | 5 |
| Ningbo Runyes Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Shenzhen Xpectvision Technology Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 4 |
Record
| Listed by | Takara Belmont Corporation, Japan |
|---|---|
| FDA product code | EHD |
| Device type | Unit, X-Ray, Extraoral With Timer |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K141293 |
| Record published | 2018-02-01 |
| Record revised | 2023-08-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 40 °C; Storage environment temperature -20 to 70 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 505 | In distribution | |
| 505 | In distribution | |
| 505 | In distribution | |
| 505 | In distribution | |
| 505 | In distribution | |
| 505 | In distribution | |
| 505 | In distribution | |
| 505 | In distribution | |
| 505 | In distribution | |
| 505 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midmark | Midmark Corporation | 148 |
| Midmark Preva IntraOral Dental X-ray System | Midmark Corporation | 136 |
| Schick AE | Sirona Dental, Inc. | 53 |
| Midmark Preva 2.0 IntraOral Dental X-ray System | Midmark Corporation | 46 |
| Xios AE | Sirona Dental, Inc. | 38 |
| X-Mind unity | DE Götzen SRL | 26 |
| Midmark Vetpro IntraOral Dental X-ray System | Midmark Corporation | 26 |
| x-mind dc | DE Götzen SRL | 17 |
| Owandy-RX DC | Owandy Radiology | 16 |
| Orthophos XG | Sirona Dental Systems Gmbh | 10 |
| Schick Elite | Sirona Dental, Inc. | 10 |
| CDR Elite | Sirona Dental, Inc. | 10 |
Showing 12 of 171. All products under Unit, X-Ray, Extraoral With Timer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141293 | 2014-09-03 |
| K093240 | 2010-03-22 |
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.