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FDA 510(k)

OPTIMA NUCLEAR TOMOGRAPHY STYSTEM

K-Number: K915470 · 1992-04-16

ApplicantGeneral Electric Co.
Decision Date1992-04-16
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPTIMA NUCLEAR TOMOGRAPHY STYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1992-04-16 under 510(k) number K915470. 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 OPTIMA NUCLEAR TOMOGRAPHY STYSTEM?

OPTIMA NUCLEAR TOMOGRAPHY STYSTEM is a medical device that received FDA 510(k) clearance on 1992-04-16. The listed applicant is General Electric Co.. The 510(k) number is K915470.

When did OPTIMA NUCLEAR TOMOGRAPHY STYSTEM receive FDA 510(k) clearance?

OPTIMA NUCLEAR TOMOGRAPHY STYSTEM received FDA 510(k) clearance on 1992-04-16, under 510(k) number K915470.

Who is the listed applicant for OPTIMA NUCLEAR TOMOGRAPHY STYSTEM?

The FDA 510(k) record lists General Electric Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTIMA NUCLEAR TOMOGRAPHY STYSTEM?

The FDA product code for OPTIMA NUCLEAR TOMOGRAPHY STYSTEM is KPS.

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Other records listing General Electric Co. as applicant

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K103489GE VEO RECONSTRUCTION OPTIONK082317GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTIONK081921GE VIVID E9 ULTRASOUNDK073297GE LOGIQ P6K072952GE ECHOPACK072797GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND

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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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