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FDA 510(k)

ACCESSPOINT, MED E-MAIL, DICOM READER

K-Number: K963936 · 1997-03-31

ApplicantBiosound, Inc.
Decision Date1997-03-31
Product CodeLMB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCESSPOINT, MED E-MAIL, DICOM READER is the device name listed in this FDA 510(k) record. The listed applicant is Biosound, Inc.. It received FDA 510(k) clearance on 1997-03-31 under 510(k) number K963936. 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 ACCESSPOINT, MED E-MAIL, DICOM READER?

ACCESSPOINT, MED E-MAIL, DICOM READER is a medical device that received FDA 510(k) clearance on 1997-03-31. The listed applicant is Biosound, Inc.. The 510(k) number is K963936.

When did ACCESSPOINT, MED E-MAIL, DICOM READER receive FDA 510(k) clearance?

ACCESSPOINT, MED E-MAIL, DICOM READER received FDA 510(k) clearance on 1997-03-31, under 510(k) number K963936.

Who is the listed applicant for ACCESSPOINT, MED E-MAIL, DICOM READER?

The FDA 510(k) record lists Biosound, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCESSPOINT, MED E-MAIL, DICOM READER?

The FDA product code for ACCESSPOINT, MED E-MAIL, DICOM READER is LMB.

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Other records listing Biosound, 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.

K971700BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCERK963262ARTOSCAN MK963662GALILEO EVOKED POTENTIALREK953716INTRACAVITY TRANSDUCERSK953530DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-AK953819DIAGNOSTIC ULTRASOUND TRANDUCER

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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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