FDA device listing
BIOK4600,ChiroSight BIOK4600 Detector and Software,ChiroSight Detector and Software,IMA-4600
FDA device listing 2055562364 · Biokinemetrics, Inc.
Key facts
| Proprietary names | BIOK4600,ChiroSight BIOK4600 Detector and Software,ChiroSight Detector and Software,IMA-4600 |
|---|---|
| Owner/operator | Biokinemetrics, Inc. |
| Owner/operator number | 10050908 |
| Premarket submissions | K092307 |
| Product codes | KPR |
| Device names | KPR - System, X-Ray, Stationary |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1680 |
| Review panels | Radiology |
| Registered establishments | BIOKINEMETRICS INC. |
| Establishment registrations | 3013714596 |
| FEI numbers | 3013714596 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database