Data / Medical devices / Japan / Mikasa X-Ray Co., Ltd.
Mikasa X-Ray Co., Ltd.: FDA-registered device maker in Yokohama-shi Kanagawa, Japan, 4 510(k) clearances
Mikasa X-Ray Co., Ltd. is registered with the FDA (registration 9610982) in Yokohama-shi Kanagawa, Japan. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated December 14, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9610982
- FEI number
- 3002807605
- Address
- 2-7-2 Shirotaecho, Minami-ku, Yokohama-shi Kanagawa, Japan, 2320023
- Owner or operator
- MIKASA X-RAY CO., LTD. (8030220)
- Roles
- Manufacturer
- First device listed
- April 26, 1979
- Registered through
- 2026
- Brand names listed
- HF1202H PowerPlus, MinXray HF100H+, MinXray HF120/60HPPWV, TR90BH portable battery operated medical x-ray unit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Mobile | IZL | 2 | 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 |
|---|---|---|---|---|---|---|
| December 14, 2018 | K182207 | TR90BH | IZL | Substantially Equivalent | Minxray, Inc. | accessdata.fda.gov |
| February 2, 2016 | K153059 | HF1202H PowerPlus Portable X-ray Equipment | IZL | Substantially Equivalent | Minxray, Inc. | accessdata.fda.gov |
| October 27, 2005 | K052721 | MINXRAY, MODEL HF100H+ | IZL | Substantially Equivalent | Minxray, Inc. | accessdata.fda.gov |
| February 2, 2004 | K040046 | MINXRAY, MODEL HF120/60H POWERPLUS | IZL | Substantially Equivalent | Minxray, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 14, 2018. 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.