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 |