philips.comCT Collaboration Live
Philips Healthcare (Suzhou) Co., Ltd.
Philips Healthcare Informatics, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2954704 | 3002971142 | Philips Healthcare Informatics, Inc. | 1 | Y | 2020-04-25 | 4430 Rosewood Drive, Suite 200 Pleasanton CA US 94588 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00884838129528 | CT Rembra - Computed Tomography X-Ray System is intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device includes Data acquisition system, detection management system and an operating console with display monitors along with patient and system supporting devices, accessories and components. | +86018911415886 | tiffany.zhang@philips.com |
| 00884838129535 | CT Rembra RT - Computed Tomography X-Ray System is intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device includes Data acquisition system, detection management system and an operating console with display monitors along with patient and system supporting devices, accessories and components. | +86018911415886 | tiffany.zhang@philips.com |
| 00884838129542 | CT Areta RT - Computed Tomography X-Ray System is intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device includes Data acquisition system, detection management system and an operating console with display monitors along with patient and system supporting devices, accessories and components. | +86018911415886 | tiffany.zhang@philips.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 96364 | 1434297284 | K182926 | IntelliSpace Radiology | LLZ | 2018-12-06 |
| 96364 | 1363211749 | K111804 | INTELLISPACE PACS 4.X | LLZ | 2011-07-28 |
| 96364 | 1471052746 | K072960 | CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET | LLZ | 2007-11-08 |
| 96364 | 1634770293 | K063267 | ISITE PACS, V 4. X | LLZ | 2006-11-09 |
| 96364 | 1398944046 | K042292 | ISITE PACS | LLZ | 2004-09-08 |
| 96364 | 1370910182 | K032096 | PHILIPS VIEWFORUM 2003 | LLZ | 2003-07-18 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LLZ | 6 | 2018-12-06 |
PMN#
CT 5300
Philips Healthcare (Suzhou) Co., Ltd.
Smart Fit Knee 3.0T
Philips Healthcare (Suzhou) Co., Ltd.
Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
Philips Healthcare (Suzhou) Co., Ltd.
Philips CT 3500
Philips Healthcare (Suzhou) Co., Ltd.
Philips Incisive CT
Philips Healthcare (Suzhou) Co., Ltd.
DS TorsoCardiac 1.5T, DS MSK S 1.5T, DS MSK M 1.5T
Philips Healthcare (Suzhou) Co., Ltd
Philips Incisive CT on Trailer
Philips Healthcare (Suzhou) Co., Ltd.
Precise Position
Philips Healthcare (Suzhou) Co., Ltd.
DigitalDiagnost C50
Philips Healthcare (Suzhou) Co., Lit.
DuraDiagnost
Philips Healthcare (Suzhou) Co., Ltd.
QLAB Advanced Quantification Software
Philips Healthcare
Collaboration Live
Philips Healthcare
QLAB Advanced Quantification Software
Philips Healthcare
Lumify Diagnostic Ultrasound System
Philips Healthcare
Access CT
Philips Healthcare (Suzhou) Co., Ltd.
QLAB Advanced Quantification Software 13
Philips Healthcare
IntelliSpace Radiology
Philips Healthcare Informatics, Inc.
Prodiva 1.5T CX And Prodiva 1.5T CS R5.4
Philips Healthcare (Suzhou) Co., Ltd.
Philips Incisive CT
Philips Healthcare (Suzhou) Co., Ltd.
Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
Philips Healthcare
QLAB Advanced Quantification Software
Philips Healthcare
DigitalDiagnost C50
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
Xperius Ultrasound System
PHILIPS HEALTHCARE
Lumify Ultrasound System
Philips Healthcare
CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
Philips Healthcare
ClearVue850 Diagnostic Ultrasound System
PHILIPS HEALTHCARE
Philips Lumify Diagnostic Ultrasound System
PHILIPS HEALTHCARE, INC.
PHILIPS IQON SPECTRAL CT
PHILIPS HEALTHCARE (CLEVELAND)
DURADIAGNOST
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
BRILLIANCE ICT
PHILIPS HEALTHCARE (CLEVELAND)
PERCUNAV SYSTEM
PHILIPS HEALTHCARE
INGENUITY DIGITAL PET/CT
PHILIPS HEALTHCARE (CLEVELAND)
IMR SOFTWARE APPLICATION
PHILIPS HEALTHCARE (CLEVELAND)
QLAB QUANTIFICATION SOFTWARE HEART MODEL
PHILIPS HEALTHCARE
PERCUNAV
PHILIPS HEALTHCARE
ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION
PHILIPS HEALTHCARE (CLEVELAND)
ST80I STRESS TEST SYSTEM
PHILIPS HEALTHCARE
INTELLISPACE ECG
PHILIPS HEALTHCARE
QLAB QUANTIFICATION SOFTWARE
PHILIPS HEALTHCARE GROUP
GUDID#
dS MSK S 1.5T - The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
2026-06-26
dS MSK M 1.5T - The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
2026-06-26
Smart Fit TorsoCardiac 1.5T - Philips Magnetic Resonance (MR) Receive-only (Rx) coils are intended to be used in conjunction with a Philips MR-system to enable trained physicians to obtain cross-sectional images of the internal structure of the head, body, or extremities, in any orientation. These images, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning.
2026-06-26
Smart Fit Knee 3.0T - Philips Magnetic Resonance (MR) Receive-only (Rx) coils are intended to be used in conjunction with a Philips MR-system to enable trained physicians to obtain cross-sectional images of the internal structure of the head, body, or extremities, in any orientation. These images, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning.
2026-06-26
Smart Fit Shoulder 1.5T - Philips Magnetic Resonance (MR) Receive-only (Rx) coils are intended to be used in conjunction with a Philips MR-system to enable trained physicians to obtain cross-sectional images of the internal structure of the head, body, or extremities, in any orientation. These images, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning.
2026-06-26
CT Areta RT - Computed Tomography X-Ray System is intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device includes Data acquisition system, detection management system and an operating console with display monitors along with patient and system supporting devices, accessories and components.
2026-04-03
CT Rembra RT - Computed Tomography X-Ray System is intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device includes Data acquisition system, detection management system and an operating console with display monitors along with patient and system supporting devices, accessories and components.
2026-04-03
CT Rembra - Computed Tomography X-Ray System is intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device includes Data acquisition system, detection management system and an operating console with display monitors along with patient and system supporting devices, accessories and components.
2026-04-03
Incisive CT
2019-10-01
dS MSK M 1.5T - The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
2022-04-17
dS TorsoCardiac 1.5T - The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
2022-04-17
DigitalDiagnost C50 - The DigitalDiagnost C50 is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
2017-10-26
DuraDiagnost - The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
2016-09-23
DuraDiagnost Compact - The DuraDiagnost Compact is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
2016-09-23
DuraDiagnost - Stationary x-ray system
2020-09-04
DigitalDiagnost C50 - Stationary x-ray system
2020-09-04
Incisive CT - The Incisive CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
2021-12-30
dS MSK S 1.5T - The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
2022-04-17
CT 5300 - The CT 5300 is a Computed Tomography X-Ray System is intended to produce images of the head and body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device includes data acquisition system, detection management system and an operating console with display monitors along with patient and system supporting devices, accessories and components.
2024-11-11
IntelliSpace Clinical Applications - "Philips IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of ""off-the-shelf"" standard computer components. Philips IntelliSpace Clinical Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. Philips IntelliSpace Clinical Applications performs viewing, image manipulation, communication, printing, and quantification of images."
2018-09-30
IntelliSpace Radiology - IntelliSpace Radiology Software (client) is a software package intended to be used by trained professionals, including but not limited to Radiologists, physicians, administrators and medical technicians. The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment. IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using display monitors approved for digital mammography.
2019-03-01
IntelliSpace PACS - IntelliSpace PACS is an image management system 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. Lossy compressed mammographic images and digitized screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
2016-09-24