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FDA 510(k)

MODIFICATION TO SCINTRON IV

K-Number: K101013 · 2010-06-07

ApplicantMiegmbh
Decision Date2010-06-07
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SCINTRON IV is the device name listed in this FDA 510(k) record. The listed applicant is Miegmbh. It received FDA 510(k) clearance on 2010-06-07 under 510(k) number K101013. 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 MODIFICATION TO SCINTRON IV?

MODIFICATION TO SCINTRON IV is a medical device that received FDA 510(k) clearance on 2010-06-07. The listed applicant is Miegmbh. The 510(k) number is K101013.

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

MODIFICATION TO SCINTRON IV received FDA 510(k) clearance on 2010-06-07, under 510(k) number K101013.

Who is the listed applicant for MODIFICATION TO SCINTRON IV?

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

What is the FDA product code for MODIFICATION TO SCINTRON IV?

The FDA product code for MODIFICATION TO SCINTRON IV is KPS.

Related Clinical Trials

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Other records listing Miegmbh 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.

K201807ANCORISK130269ECAT SCINTRON PETK101768MIE SCINTRON GAMMA CAMERA SYSTEMS

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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