Data / Medical devices / United States / Biokinemetrics Inc.
Biokinemetrics Inc.: FDA-registered device maker in Carroll, IA, United States, 3 510(k) clearances
Biokinemetrics Inc. is registered with the FDA (registration 3013714596) in Carroll, IA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 13, 2019. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3013714596
- Address
- 211 E. 4th St., Carroll, IA, United States, 51401
- Owner or operator
- Biokinemetrics, Inc. (10050908)
- Roles
- Manufacturer
- First device listed
- January 15, 2016
- Registered through
- 2027
- Brand names listed
- BIOK4600, BIOK7600 Flat Panel Detector, BIOK7600W Wireless Flat Panel Detector, ChiroSight, ChiroSight BIOK4600 Detector and Software, ChiroSight BIOK7600 Flat Panel Detector and Software, ChiroSight BIOK7600W Wireless Flat Panel Detector and Software, ChiroSight Detector and Software and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 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 |
|---|---|---|---|---|---|---|
| March 13, 2019 | K190311 | BIOK7600 Flat Panel Detector | MQB | Substantially Equivalent | Biokinemetrics, Inc. | accessdata.fda.gov |
| March 13, 2019 | K190300 | BIOK7600W Wireless Flat Panel Detector | MQB | Substantially Equivalent | Biokinemetrics, Inc. | accessdata.fda.gov |
| August 25, 2009 | K092307 | IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR | KPR | Substantially Equivalent | Imasight, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Stationary
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
Updated March 13, 2019. 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.