FDA device listing
Blue Sky Plan Software
FDA device listing 1195757214 · BLUE SKY BIO, LLC
Key facts
| Proprietary names | Blue Sky Plan Software |
|---|---|
| Owner/operator | BLUE SKY BIO, LLC |
| Owner/operator number | 9040515 |
| Premarket submissions | K090607 |
| Product codes | LLZ |
| Device names | LLZ - System, Image Processing, Radiological |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.2050 |
| Review panels | Radiology |
| Registered establishments | BLUE SKY BIO, LLC |
| Establishment registrations | 3003402534 |
| FEI numbers | 3003402534 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1,000+ 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