# K192455: Merge PACS

- Pathway: 510(k) (Traditional)
- Applicant: Merge Healthcare Incorporated
- Decided: Oct 17, 2019 after 38 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K913770 (1991). 117 ancestors in all.
No later device cites it as a predicate yet.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173475: Merge PACS, Merge Healthcare Incorporated (2017) Summary page 6.

## Recalls of this device
- Jul 22, 2026 · Class II · Z-3004-2026: Software issue may cause measurements to be displayed inaccurately.
- Jun 30, 2026 · Class II · Z-2874-2026: Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.
- Jun 30, 2026 · Class II · Z-2875-2026: Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.
- Aug 6, 2020 · Class II · Z-2944-2020: Measurements done on the Merge PACS generated MPR s may have incorrect measurements.

## Indications for use
Merge PACS™ is a Picture Archiving and Communication System (PACS) for multi-modality (CT, MR, PT, US, MG, BTO, CR, DR/DX, NM, XA, RF, secondary capture (SC), and other DICOM-compliant modalities) image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies and other patient data. Intended clinical users include radiologists, orthopedic and other surgeons, referring physicians, technologists, and other qualified medical professionals. Data can be received directly from acquisition modalities, CAD systems, and other image processing systems, or indirectly via importing. Data that is not DICOM-compliant, such as photos, can be converted to DICOM format by Merge PACS. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR, and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae). The Real Time Worklist (RTWL) displays the real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, configurable components. The Patient Dashboard provides a composite view of patient data, both imaging and non-imaging. Multi-tier patient identity matching provides a comprehensive view even when dealing with multiple disparate patient identities. Order and report information generated by the HIS/RIS and report creation systems are received and displayed via the transmission of HL7 messaging. Lossless (reversible) and lossy (irreversible) image compression are supported for viewing, storage and communication. Merge PACS displays full fidelity DICOM images for use in the diagnostic interpretation of mammography using MG or BTO images. Thick slab MIP presentation can be applied to BTO images. Lossy compressed images and digitized screen film images must not be used for primary diagnosis of mammography studies, and only display monitors that have regulatory clearance for mammography interpretation should be used for the interpretation of mammography studies.

Source page: https://510kreport.com/device/K192455
Methodology: https://510kreport.com/methodology