IntelliSpace Radiology 836344

GUDID 00884838123809

IntelliSpace Radiology is a software package intended to be used by trained professionals, including but not limited to 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 software supports receiving, sending, printing, and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, CR, DX, DR, RF, RT, MG, SC, VL, and OP as well as hospital/radiology information systems. 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.

Philips Medical Systems Nederland B.V.

Radiology picture archiving and communication system workstation

• Primary Device ID: 00884838123809
• NIH Device Record Key: 45937cec-e2dd-4b21-b799-ec52cfbc852f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntelliSpace Radiology
• Version Model Number: 4.7.X
• Catalog Number: 836344
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838123809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182926

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-12
• Device Publish Date: 2024-04-04

Devices Manufactured by Philips Medical Systems Nederland B.V.

• 00884838125940 - IntelliSpace Clinical Applications: 2024-11-11 IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware.
• 00884838121270 - Philips IntelliSite Pathology Solution: 2024-10-16 Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system.
• 00884838118454 - Philips: 2024-07-26 MRI Needle Block 8G
• 00884838118461 - Philips: 2024-07-26 Fiducial Marker Sleeve Assembly
• 00884838118478 - Philips: 2024-07-26 FIDUCIAL MARKER GRID BLOCK ASSEMBLY
• 00884838118485 - Philips: 2024-07-26 MRI Needle Block 12G
• 00884838118492 - Philips: 2024-07-26 MRI Needle Block 14G
• 00884838118508 - Philips: 2024-07-26 MRI Needle Block 16G