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FDA 510(k)

ECAT SCINTRON PET

K-Number: K130269 · 2013-04-19

ApplicantMiegmbh
Decision Date2013-04-19
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECAT SCINTRON PET is the device name listed in this FDA 510(k) record. The listed applicant is Miegmbh. It received FDA 510(k) clearance on 2013-04-19 under 510(k) number K130269. 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 ECAT SCINTRON PET?

ECAT SCINTRON PET is a medical device that received FDA 510(k) clearance on 2013-04-19. The listed applicant is Miegmbh. The 510(k) number is K130269.

When did ECAT SCINTRON PET receive FDA 510(k) clearance?

ECAT SCINTRON PET received FDA 510(k) clearance on 2013-04-19, under 510(k) number K130269.

Who is the listed applicant for ECAT SCINTRON PET?

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 ECAT SCINTRON PET?

The FDA product code for ECAT SCINTRON PET is KPS.

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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.

K201807ANCORISK101768MIE SCINTRON GAMMA CAMERA SYSTEMSK101013MODIFICATION TO SCINTRON IV

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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