The following data is part of a premarket notification filed by Imbio, Llc with the FDA for Imbio Segmentation Editing Tool Software.
| Device ID | K180129 |
| 510k Number | K180129 |
| Device Name: | Imbio Segmentation Editing Tool Software |
| Classification | System, Image Processing, Radiological |
| Applicant | Imbio, LLC 807 Broadway St NE, #350 Minneapolis, MN 55413 |
| Contact | Vipul Goel |
| Correspondent | Vipul Goel Imbio, LLC 807 Broadway St NE, #350 Minneapolis, MN 55413 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-17 |
| Decision Date | 2018-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850894007209 | K180129 | 000 |
| 00850894007445 | K180129 | 000 |
| 00850894007759 | K180129 | 000 |