The following data is part of a premarket notification filed by Onepacs, Llc with the FDA for Onepacs System.
| Device ID | K181460 |
| 510k Number | K181460 |
| Device Name: | OnePacs System |
| Classification | System, Image Processing, Radiological |
| Applicant | OnePacs, LLC 530 Lytton Ave Palo Alto, CA 94301 |
| Contact | Justin Falk |
| Correspondent | Justin Falk OnePacs, LLC 530 Lytton Ave Palo Alto, CA 94301 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-04 |
| Decision Date | 2018-10-11 |
| Summary: | summary |