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FDA 510(k)

SCINTRON IV

K-Number: K953193 · 1995-10-24

ApplicantMedical Imaging Electronics America, Inc.
Decision Date1995-10-24
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SCINTRON IV is the device name listed in this FDA 510(k) record. The listed applicant is Medical Imaging Electronics America, Inc.. It received FDA 510(k) clearance on 1995-10-24 under 510(k) number K953193. 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 SCINTRON IV?

SCINTRON IV is a medical device that received FDA 510(k) clearance on 1995-10-24. The listed applicant is Medical Imaging Electronics America, Inc.. The 510(k) number is K953193.

When did SCINTRON IV receive FDA 510(k) clearance?

SCINTRON IV received FDA 510(k) clearance on 1995-10-24, under 510(k) number K953193.

Who is the listed applicant for SCINTRON IV?

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

What is the FDA product code for SCINTRON IV?

The FDA product code for SCINTRON IV is KPS.

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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

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

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