← Back to catalogue

IntelliSpace Radiology

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 836344510(k) K182926

by Philips Healthcare Informatics, Inc.

Identity

Trade Name
IntelliSpace Radiology EUDAMEDFDA UDI
Generic Name
Radiology picture archiving and communication system workstation FDA UDI
Device Name
IntelliSpace Radiology EUDAMED
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. FDA UDI
Model / Reference
836344 EUDAMED
IntelliSpace Radiology - 4 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
836344 FDA UDI
Primary DI / UDI-DI
00884838091740 EUDAMEDFDA UDI
Basic UDI-DI
B-00884838091740 EUDAMED
510(k) Number
K182926 FDA UDI
FDA Product Code
LLZ FDA UDI
EMDN Code
Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
GMDN Term
Radiology picture archiving and communication system workstation FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Special Device Type
-1192 EUDAMED
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

IntelliSpace Radiology by Philips Healthcare Informatics, Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Philips Healthcare Informatics, Inc.
EUDAMED SRN
US-MF-000002160
Authorised Representative
Philips Medical Systems Nederland B.V. NL-AR-000001422

Sources (3)

  • EUDAMED 79901fa1-b3e3-49a7-bb44-af97c9fae13f 85 fields · synced Jun 18, 2026
  • FDA UDI 5dcd3f11-b217-4a9a-a0bd-f6afb45d0461 36 fields · synced May 30, 2026
  • FDA 510(k) K182926 1 fields · synced May 18, 2026