The following data is part of a premarket notification filed by Imaging Biometrics, Llc with the FDA for Ib Clinic.
| Device ID | K123302 |
| 510k Number | K123302 |
| Device Name: | IB CLINIC |
| Classification | System, Image Processing, Radiological |
| Applicant | IMAGING BIOMETRICS, LLC 13416 Watertown Plank Rd Suite 260 Elm Grove, WI 53122 |
| Contact | Mike Schmainda |
| Correspondent | Mike Schmainda IMAGING BIOMETRICS, LLC 13416 Watertown Plank Rd Suite 260 Elm Grove, WI 53122 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-23 |
| Decision Date | 2013-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B319IBRADTECH20 | K123302 | 000 |
| B319IBCLINIC20 | K123302 | 000 |
| B319IBDCE120 | K123302 | 000 |
| B319IBDCE20 | K123302 | 000 |
| B319IBDELTASUITE120 | K123302 | 000 |
| B319IBDELTASUITE20 | K123302 | 000 |
| B319IBDIFFUSION12 | K123302 | 000 |
| B319IBDIFFUSION20 | K123302 | 000 |
| B319IBNEURO120 | K123302 | 000 |
| B319IBNEURO20 | K123302 | 000 |
| B319IBRADTECH120 | K123302 | 000 |
| B319IBCLINIC120 | K123302 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IB CLINIC 85809191 4704257 Live/Registered |
Imaging BioMetrics, LLC 2012-12-21 |