Philips Digital Cardiac Imaging (Dci) System

Q: What is the product code of K885327?

The FDA product code is LMB – Device, Digital Image Storage, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2010.

FDA 510(k) K885327 · Philips Medical Systems North America, Inc.

Substantially Equivalent

510(k) numberK885327

Submission

Device name: Philips Digital Cardiac Imaging (Dci) System
Applicant: Philips Medical Systems North America, Inc.
Shelton, CT, US
Received: December 28, 1988
Decision date: May 11, 1989
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: LMB – Device, Digital Image Storage, Radiological
Device class: Class I (low risk)
Regulation: 21 CFR 892.2010
Specialty: Radiology

Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.

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K980243	Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis)LMB · Traditional	Parameter Developments, Inc.	04/03/1998SE
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K972380	Kodak Digital Science (KDS) Medical Image and Information Library (Miil)LMB · Traditional	Eastman Kodak Company	09/11/1997SE
K971848	TDK Medical Grade Cd-RLMB · Traditional	Tdk Electronics Corporation of America	08/15/1997SE
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Questions and answers

When was Philips Digital Cardiac Imaging (Dci) System cleared by the FDA?

Philips Digital Cardiac Imaging (Dci) System (K885327) received a 510(k) decision of Substantially Equivalent on May 11, 1989, 134 days after the submission was received.

What is the product code of K885327?

The FDA product code is LMB – Device, Digital Image Storage, Radiological, a Class I (low risk) device regulated under 21 CFR 892.2010.