The following data is part of a premarket notification filed by Nucleushealth, Llc with the FDA for Nucleus Image Management System.
| Device ID | K171130 |
| 510k Number | K171130 |
| Device Name: | Nucleus Image Management System |
| Classification | System, Image Processing, Radiological |
| Applicant | NucleusHealth, LLC 13280 Evening Creek Dr. San Diego, CA 91928 |
| Contact | Linda Moore |
| Correspondent | Mark Job 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 | 2017-04-17 |
| Decision Date | 2017-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17540262140019 | K171130 | 000 |