HICAT Air
System, Image Processing, Radiological
HICAT GmbH
The following data is part of a premarket notification filed by Hicat Gmbh with the FDA for Hicat Air.
Pre-market Notification Details
| Device ID | K152661 |
| 510k Number | K152661 |
| Device Name: | HICAT Air |
| Classification | System, Image Processing, Radiological |
| Applicant | HICAT GmbH Brunnenallee 6 Bonn, DE 53177 |
| Contact | Frederik Kunze |
| Correspondent | Frederik Kunze HICAT GmbH Brunnenallee 6 Bonn, DE 53177 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-17 |
| Decision Date | 2015-11-16 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B06965436510 | K152661 | 000 |
| D776AIRV200 | K152661 | 000 |
| D776AIRV20400 | K152661 | 000 |
Trademark Results [HICAT Air]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HICAT AIR 79144862 4693807 Live/Registered |
hiCAT GmbH 2013-11-28 |
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