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FDA 510(k)

PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM

K-Number: K885327 · 1989-05-11

ApplicantPhilips Medical Systems North America, Inc.
Decision Date1989-05-11
Product CodeLMB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America, Inc.. It received FDA 510(k) clearance on 1989-05-11 under 510(k) number K885327. The device is classified under product code LMB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM?

PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM is a medical device that received FDA 510(k) clearance on 1989-05-11. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K885327.

When did PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM receive FDA 510(k) clearance?

PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM received FDA 510(k) clearance on 1989-05-11, under 510(k) number K885327.

Who is the listed applicant for PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM?

The FDA 510(k) record lists Philips Medical Systems North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM?

The FDA product code for PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM is LMB.

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Other records listing Philips Medical Systems North America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102005ALLURA XPER OR TABLE SERIESK062233HEARTSTART MRX MONITOR/DEFIBRILLATORK062283THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORSK061052THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90K050151MULTIDIAGNOST ELEVAK042867PHILIPS ORTHOPAEDIC APPLICATIONS

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Related Devices (Code: LMB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992131SAMSUNG RAYPAX LONG TERM ARCHIVESamsung Sds Co., Ltd.K984405ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp.K983447WISE (II) IMAGE MANAGEMENT SYSTEMSectra-Imtec ABK980243PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)Parameter Developments, Inc.K973463OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVEO Tech, Inc.K973413ID. STORE (RELEASE 2.0)I.S.G. Technologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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