The following data is part of a premarket notification filed by Ultrarad Corporation with the FDA for Ultrapacs.
Device ID | K051813 |
510k Number | K051813 |
Device Name: | ULTRAPACS |
Classification | System, Image Processing, Radiological |
Applicant | ULTRARAD CORPORATION 1600 MANCHESTER WAY Corinth, TX 76210 |
Contact | Carl Alletto |
Correspondent | Carl Alletto ULTRARAD CORPORATION 1600 MANCHESTER WAY Corinth, TX 76210 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-05 |
Decision Date | 2005-08-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860001148589 | K051813 | 000 |
00860001148503 | K051813 | 000 |
00860001148510 | K051813 | 000 |
00860001148527 | K051813 | 000 |
00860001148534 | K051813 | 000 |
00860001148541 | K051813 | 000 |
00860001148558 | K051813 | 000 |
00860001148565 | K051813 | 000 |
00860001148572 | K051813 | 000 |
00860002319803 | K051813 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ULTRAPACS 74453187 1952201 Dead/Cancelled |
A.L.I. TECHNOLOGIES, INC. 1993-10-27 |