The following data is part of a premarket notification filed by Carestream Heatlh, Inc. with the FDA for Carestream Image Suite.
| Device ID | K100094 |
| 510k Number | K100094 |
| Device Name: | CARESTREAM IMAGE SUITE |
| Classification | System, Image Processing, Radiological |
| Applicant | CARESTREAM HEATLH, INC. 150 VERONA STREET Rochester, NY 14608 |
| Contact | John Pardo |
| Correspondent | John Pardo CARESTREAM HEATLH, 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 | 2010-01-13 |
| Decision Date | 2010-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889971055989 | K100094 | 000 |
| 60889976701171 | K100094 | 000 |