The following data is part of a premarket notification filed by Biokinemetrics Inc. with the FDA for Aquarius 8600 Digital Radiography Sensor.
| Device ID | K181565 |
| 510k Number | K181565 |
| Device Name: | Aquarius 8600 Digital Radiography Sensor |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Biokinemetrics Inc. 211 East 4th Street Carroll, IA 51401 |
| Contact | Steven Kraus |
| Correspondent | Steven Kraus Biokinemetrics Inc. 211 East 4th Street Carroll, IA 51401 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-14 |
| Decision Date | 2018-07-13 |
| Summary: | summary |