The following data is part of a premarket notification filed by Heartlab, Inc. with the FDA for Dicomview.
| Device ID | K954479 |
| 510k Number | K954479 |
| Device Name: | DICOMVIEW |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | HEARTLAB, INC. 146 WESTMINSTER ST. SUITE 500 Providence, RI 02903 |
| Contact | Richard Petrocelli |
| Correspondent | Richard Petrocelli HEARTLAB, INC. 146 WESTMINSTER ST. SUITE 500 Providence, RI 02903 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-26 |
| Decision Date | 1996-02-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DICOMVIEW 75046430 2086494 Dead/Cancelled |
HEARTLAB, INC. 1996-01-22 |