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 |