The following data is part of a premarket notification filed by Parameter Developments, Inc. with the FDA for Parameter Developments Dicom Archival Server, (das)/dicom Intranet Service (dis).
Device ID | K980243 |
510k Number | K980243 |
Device Name: | PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) |
Classification | Device, Digital Image Storage, Radiological |
Applicant | PARAMETER DEVELOPMENTS, INC. 16303 PANORAMIC WAY San Leandro, CA 94578 -1116 |
Contact | Gary J Allsebrook |
Correspondent | Gary J Allsebrook PARAMETER DEVELOPMENTS, INC. 16303 PANORAMIC WAY San Leandro, CA 94578 -1116 |
Product Code | LMB |
CFR Regulation Number | 892.2010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-01-23 |
Decision Date | 1998-04-03 |
Summary: | summary |