| K-number | K251168 |
| Device name | Image Suite |
| Applicant | Carestream Health, Inc. |
| Product code | LLZ |
| Device class | Class II |
| Decision date | Sep 4, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.2050 |
Image Suite is radiographic imaging software that performs patient registration, review, reporting, archiving, and printing of images from Carestream CR/DR devices and compatible third-party modalities (US, MR, CT). It serves as a web-based PACS for radiologists and trained healthcare professionals to view and make diagnostic/therapeutic decisions on digital medical images.
Image Suite uses Eclipse II image processing software (upgraded from Eclipse), supports multi-monitor displays, runs on Windows or iOS with Internet Explorer or Safari browsers, and maintains DICOM compatibility. New features added include Tube & PICC Line visualization, pneumothorax visualization, bone suppression, expanded multiple looks (four vs. one), smart grid, and X-Factor—all previously cleared in other Carestream products (K120062, K133442, K163157).
Not stated in this summary.
The device is substantially equivalent because it performs identical primary functions to the predicate (image management, review, archiving, display) with the same intended use for radiologist diagnostic decision-making. All new features were previously cleared on other Carestream CR/DR systems using the same Eclipse processing software, and performance testing confirmed design outputs met requirements under simulated use conditions with predefined acceptance criteria met.
View the full FDA submission: accessdata.fda.gov