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FDA 510(k)

DC-1 CARDIAC IMAGING MODULE

K-Number: K811556 · 1981-07-10

ApplicantDiasonics, Inc.
Decision Date1981-07-10
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DC-1 CARDIAC IMAGING MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Diasonics, Inc.. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811556. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DC-1 CARDIAC IMAGING MODULE?

DC-1 CARDIAC IMAGING MODULE is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is Diasonics, Inc.. The 510(k) number is K811556.

When did DC-1 CARDIAC IMAGING MODULE receive FDA 510(k) clearance?

DC-1 CARDIAC IMAGING MODULE received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811556.

Who is the listed applicant for DC-1 CARDIAC IMAGING MODULE?

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

What is the FDA product code for DC-1 CARDIAC IMAGING MODULE?

The FDA product code for DC-1 CARDIAC IMAGING MODULE is DXK.

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Other records listing Diasonics, 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.

K962662VINGMED SOUND COLOR FLOW MAPPING SYSTEMK924079CFM-800 COLOR FLOW MAPPING SYSTEMK911435CPA/3.5 MHZ PROBEK905200SACA, 3.5 MHZ PROBEK903562CW DOPPLER 2.25 MHZ PROBEK903984CW DOPPLER/4.5 MHZ

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Related Devices (Code: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.

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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