The following data is part of a premarket notification filed by Nucleushealth, Llc with the FDA for Nucleus.io.
| Device ID | K203249 |
| 510k Number | K203249 |
| Device Name: | Nucleus.io |
| Classification | System, Image Processing, Radiological |
| Applicant | NucleusHealth, LLC 13280 Evening Creek Dr. Ste 110 San Diego, CA 92128 |
| Contact | Zachary Wright |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-11-04 |
| Decision Date | 2020-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17540262160017 | K203249 | 000 |
| 17540262160130 | K203249 | 000 |
| 17540262160116 | K203249 | 000 |
| 17540262160109 | K203249 | 000 |
| 17540262160093 | K203249 | 000 |
| 17540262160086 | K203249 | 000 |
| 17540262160079 | K203249 | 000 |
| 17540262160062 | K203249 | 000 |
| 17540262160048 | K203249 | 000 |
| 17540262160055 | K203249 | 000 |
| 17540262160031 | K203249 | 000 |
| 17540262160024 | K203249 | 000 |
| 17540262140026 | K203249 | 000 |
| 17540262160147 | K203249 | 000 |