Philips Healthcare Informatics, Inc.
Philips Healthcare Informatics, Inc. holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2018, with 4 FDA device recalls on record.
Top product codes for Philips Healthcare Informatics, Inc.
FDA recalls by Philips Healthcare Informatics, Inc.
- Z-2338-2020 — IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
- Z-2252-2014 — Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
- Z-1646-2014 — Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management.
- Z-0269-2014 — Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Philips Healthcare Informatics, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.