The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Quantem.
Device ID | K963162 |
510k Number | K963162 |
Device Name: | QUANTEM |
Classification | System, Tomography, Computed, Emission |
Applicant | ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
Contact | Thomas J Spackman, M.d.,f.a.c.r. |
Correspondent | Thomas J Spackman, M.d.,f.a.c.r. ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-14 |
Decision Date | 1996-11-12 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
QUANTEM 88575546 not registered Live/Pending |
DelphX Corporation 2019-08-12 |
QUANTEM 87633677 not registered Dead/Abandoned |
DelphX Corporation 2017-10-04 |
QUANTEM 77135648 3347675 Dead/Cancelled |
TELEDYNE DIGITAL IMAGING US, INC. 2007-03-20 |
QUANTEM 76719654 not registered Dead/Abandoned |
DelphX Corporation 2016-08-23 |
QUANTEM 75652579 2329084 Dead/Cancelled |
Quantem Corporation 1999-03-03 |
QUANTEM 74400490 1827331 Dead/Cancelled |
Emory University 1993-06-11 |