The following data is part of a premarket notification filed by Segami Corp., Inc. with the FDA for Modification To Mirage.
Device ID | K010726 |
510k Number | K010726 |
Device Name: | MODIFICATION TO MIRAGE |
Classification | System, Image Processing, Radiological |
Applicant | SEGAMI CORP., INC. 8335 GUILFORD RD. SUITE I Columbia, MD 21046 |
Contact | Philippe A Briandet |
Correspondent | Philippe A Briandet SEGAMI CORP., INC. 8335 GUILFORD RD. SUITE I Columbia, MD 21046 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-03-12 |
Decision Date | 2001-04-26 |