The following data is part of a premarket notification filed by Imbio Llc with the FDA for Lung Density Analysis.
| Device ID | K141069 |
| 510k Number | K141069 |
| Device Name: | Lung Density Analysis |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | IMBIO LLC 227 COLFAX AVE N SUITE 144 Minneapolis, MN 55405 |
| Contact | Jason Sheard |
| Correspondent | Jason Sheard IMBIO LLC 227 COLFAX AVE N SUITE 144 Minneapolis, MN 55405 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-24 |
| Decision Date | 2014-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850894007322 | K141069 | 000 |
| 00850894007629 | K141069 | 000 |
| 00850894007667 | K141069 | 000 |
| 00850894007681 | K141069 | 000 |
| 00850894007674 | K141069 | 000 |
| 00850894007780 | K141069 | 000 |
| 00850894007773 | K141069 | 000 |
| 00850894007827 | K141069 | 000 |
| 00850894007810 | K141069 | 000 |
| 00850894007858 | K141069 | 000 |
| 00850894007841 | K141069 | 000 |
| 00850894007865 | K141069 | 000 |
| 00850894007612 | K141069 | 000 |
| 00850894007599 | K141069 | 000 |
| 00850894007582 | K141069 | 000 |
| 00850894007292 | K141069 | 000 |
| 00850894007094 | K141069 | 000 |
| 00850894007070 | K141069 | 000 |
| 00850894007056 | K141069 | 000 |
| 00850894007032 | K141069 | 000 |
| 00850894007025 | K141069 | 000 |
| 00850894007018 | K141069 | 000 |
| 00850894007414 | K141069 | 000 |
| 00850894007506 | K141069 | 000 |
| 00850894007551 | K141069 | 000 |
| 00850894007575 | K141069 | 000 |
| 00850894007735 | K141069 | 000 |