Achieva/Intera 782121

GUDID 00884838101142

R5.7 brings software and application improvements. These include SmartExam enhancements with Quick Smart Survey. Other SW enhancements are including Prescan Redesign, Automated Analysis Software to generate data for American College of Radiology (ACR) Accreditation etc. R5.7 is also enabler for optional new clinical features like 4D FreeBreathing, MR Elastography Extension, MultiBand SENSE with dS Head coil and in 1.5T & Diffusion Excellence Pack.

Philips Medical Systems Nederland B.V.

Full-body MRI system, superconducting magnet

• Primary Device ID: 00884838101142
• NIH Device Record Key: d8c204ad-55bd-48c1-ae44-c9d7ecc99dcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Achieva/Intera
• Version Model Number: Upgrades Achieva/Intera to R5.7
• Catalog Number: 782121
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	00884838101142 [Primary]

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-12-15
• Device Publish Date: 2025-10-01

Devices Manufactured by Philips Medical Systems Nederland B.V.

• 00884838128415 - Ingenia: 2026-01-15 BlueSeal SE
• 00884838128422 - Ingenia: 2026-01-15 BlueSeal XE
• 00884838128439 - Ingenia: 2026-01-15 MR 7700
• 00884838128446 - Ingenia: 2026-01-15 MR 5300
• 00884838128453 - Ingenia: 2026-01-15 Ingenia Elition S
• 00884838128460 - Ingenia: 2026-01-15 Ingenia Elition X
• 00884838128477 - Ingenia, MR5300, MR7700, Achieva: 2026-01-15 Ingenia Ambition S
• 00884838128484 - Ingenia 3.0T: 2026-01-15 Ingenia Ambition X