Data / Medical devices / Japan / Takara Medical Co., Ltd.
Takara Medical Co., Ltd.: FDA-registered device maker in Amagasaki Hyogo, Japan, 3 510(k) clearances
Takara Medical Co., Ltd. is registered with the FDA (registration 3010972172) in Amagasaki Hyogo, Japan. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 3, 2014. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010972172
- Address
- 5-15, Nukata-cho, Amagasaki Hyogo, Japan, 661-0962
- Owner or operator
- TAKARA BELMONT CORPORATION (8031613)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 14, 1994
- Registered through
- 2027
- Brand names listed
- 097 Bel-Ray II, PHOT-X II, MODEL 303, PHOT-X-IIS Model 505
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 3, 2014 | K141293 | PHOT-X IIS MODEL 505 | EHD | Substantially Equivalent | Takara Belmont Corporation | accessdata.fda.gov |
| March 22, 2010 | K093240 | BELRAY II | EHD | Substantially Equivalent | Takara Belmont Corp. | accessdata.fda.gov |
| September 7, 2004 | K042260 | PHOT-X II, MODEL 303 | EHD | Substantially Equivalent | Takara Belmont USA, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of Unit, X-Ray, Extraoral With Timer
Updated September 3, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.