The following data is part of a premarket notification filed by Terarecon, Inc. with the FDA for Intuition.
Device ID | K121916 |
510k Number | K121916 |
Device Name: | INTUITION |
Classification | System, Image Processing, Radiological |
Applicant | TERARECON, INC. 4000 E 3rd Ave Ste 200 Foster City, CA 94404 |
Contact | Robert Taylor |
Correspondent | Robert Taylor TERARECON, INC. 4000 E 3rd Ave Ste 200 Foster City, CA 94404 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-07-02 |
Decision Date | 2013-04-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
INTUITION6 | K121916 | 000 |
INTUITION5 | K121916 | 000 |
INTUITION4 | K121916 | 000 |
INTUITION11 | K121916 | 000 |
INTUITION10 | K121916 | 000 |
INTUITION04 | K121916 | 000 |