The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Carestream Pacs.
Device ID | K110919 |
510k Number | K110919 |
Device Name: | CARESTREAM PACS |
Classification | System, Image Processing, Radiological |
Applicant | CARESTREAM HEALTH, INC. 150 VERONA STREET Rochester, NY 14608 |
Contact | Linda Stewart |
Correspondent | Linda Stewart CARESTREAM HEALTH, INC. 150 VERONA STREET Rochester, NY 14608 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-01 |
Decision Date | 2011-10-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
60889971047809 | K110919 | 000 |
60889971041692 | K110919 | 000 |
00884838100336 | K110919 | 000 |