The following data is part of a premarket notification filed by Softlink International Inc. with the FDA for Hcp Dicom Net.
Device ID | K023467 |
510k Number | K023467 |
Device Name: | HCP DICOM NET |
Classification | System, Image Processing, Radiological |
Applicant | SOFTLINK INTERNATIONAL INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
Contact | Susan D Goldstein-falk |
Correspondent | Susan D Goldstein-falk SOFTLINK INTERNATIONAL INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-16 |
Decision Date | 2003-01-07 |
Summary: | summary |