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FDA 510(k)

CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER

K-Number: K972509 · 1997-09-08

ApplicantNuccardiac Software, Inc.
Decision Date1997-09-08
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER is the device name listed in this FDA 510(k) record. The listed applicant is Nuccardiac Software, Inc.. It received FDA 510(k) clearance on 1997-09-08 under 510(k) number K972509. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER?

CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER is a medical device that received FDA 510(k) clearance on 1997-09-08. The listed applicant is Nuccardiac Software, Inc.. The 510(k) number is K972509.

When did CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER receive FDA 510(k) clearance?

CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER received FDA 510(k) clearance on 1997-09-08, under 510(k) number K972509.

Who is the listed applicant for CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER?

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

What is the FDA product code for CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER?

The FDA product code for CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER is KPS.

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Other records listing Nuccardiac Software, 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.

K970288CLINICAL DIAGNOSTIC SOFTWAREK944720COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTIONK942363CEQUAL-QUANTITATIVE ANALYSISK932701CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSISK922671CEDARS SINAI QUANTITATIVE THALLIUM 201 ANALYSISK915644CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS

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Related Devices (Code: KPS)

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.

K261305MICSI-PETMicrostructure Imaging, Inc.K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd.K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 FamilySiemens Medical Solutions USA, Inc.K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)Spectrum Dynamics Medical, Ltd.

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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