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 |