The following data is part of a premarket notification filed by Terarecon, Inc. with the FDA for Aquarius Workstation.
Device ID | K011142 |
510k Number | K011142 |
Device Name: | AQUARIUS WORKSTATION |
Classification | System, Image Processing, Radiological |
Applicant | TERARECON, INC. 200 GREGORY LN. SUITE C-100 Pleasent Hill, CA 94523 -3389 |
Contact | David W Schlerf |
Correspondent | David W Schlerf TERARECON, INC. 200 GREGORY LN. SUITE C-100 Pleasent Hill, CA 94523 -3389 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-04-13 |
Decision Date | 2001-05-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
INTUITION1 | K011142 | 000 |
INTUITION8 | K011142 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() AQUARIUS WORKSTATION 76322419 2600983 Live/Registered |
TeraRecon, Inc. 2001-10-09 |