The following data is part of a premarket notification filed by Anatomage, Inc with the FDA for Invivo Dental.
| Device ID | K123519 |
| 510k Number | K123519 |
| Device Name: | INVIVO DENTAL |
| Classification | System, Image Processing, Radiological |
| Applicant | ANATOMAGE, INC 111N. MARKET ST, STE 800 San Jose, CA 95113 |
| Contact | Mike Mendez |
| Correspondent | Mike Mendez ANATOMAGE, INC 111N. MARKET ST, STE 800 San Jose, CA 95113 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-15 |
| Decision Date | 2013-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852060007105 | K123519 | 000 |
| 00852060007068 | K123519 | 000 |
| 00852060007051 | K123519 | 000 |
| 00852060007044 | K123519 | 000 |
| 00852060007037 | K123519 | 000 |
| 00852060007006 | K123519 | 000 |
| 00852060007242 | K123519 | 000 |
| 00852060007266 | K123519 | 000 |