The following data is part of a premarket notification filed by Axon Medical Technologies Corp. with the FDA for Viewing Client Mobile.
| Device ID | K141536 |
| 510k Number | K141536 |
| Device Name: | VIEWING CLIENT MOBILE |
| Classification | System, Image Processing, Radiological |
| Applicant | AXON MEDICAL TECHNOLOGIES CORP. 18 TANAGER AVENUE, SUITE 303 Toronto, Ontario, CA M4g 3r1 |
| Contact | Chas Yu |
| Correspondent | Chas Yu AXON MEDICAL TECHNOLOGIES CORP. 18 TANAGER AVENUE, SUITE 303 Toronto, Ontario, CA M4g 3r1 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-10 |
| Decision Date | 2015-03-06 |
| Summary: | summary |