Data / Medical devices / United States / Mie America, Inc.
Mie America, Inc.: FDA-registered device maker in Elk Grove Village, IL, United States, 6 510(k) clearances
Mie America, Inc. is registered with the FDA (registration 1423348) in Elk Grove Village, IL, United States. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 27, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1423348
- FEI number
- 3000210013
- Address
- 420 Bennett RD., Elk Grove Village, IL, United States, 60007
- Owner or operator
- MIE GMBH (9028781)
- Roles
- Complaint file establishment
- First device listed
- July 20, 1998
- Registered through
- 2026
- Brand names listed
- ANCORIS, ECAM SCINTRON, ECAT Scintron PET, MIE - DIACAM SCINTRON, MIE - LFOV SCINTRON, MIE - ORBITER SCINTRON, MIE - SD-X 37 SCINTRON, SCINTRON
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Scintillation (Gamma) | IYX | 1 | Complaint file establishment | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| August 27, 2020 | K201807 | ANCORIS | KPS | Substantially Equivalent | Miegmbh | accessdata.fda.gov |
| April 19, 2013 | K130269 | ECAT SCINTRON PET | KPS | Substantially Equivalent | Miegmbh | accessdata.fda.gov |
| October 5, 2010 | K101768 | MIE SCINTRON GAMMA CAMERA SYSTEMS | KPS | Substantially Equivalent | Miegmbh | accessdata.fda.gov |
| June 7, 2010 | K101013 | MODIFICATION TO SCINTRON IV | KPS | Substantially Equivalent | Miegmbh | accessdata.fda.gov |
| January 27, 2006 | K053086 | MIE - GAMMA CAMERA SYSTEMS | KPS | Substantially Equivalent | Mie America, Inc. | accessdata.fda.gov |
| October 24, 1995 | K953193 | SCINTRON IV | KPS | Substantially Equivalent | Medical Imaging Electronics America, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 27, 2020. 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.