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FDA 510(k)

MIE - GAMMA CAMERA SYSTEMS

K-Number: K053086 · 2006-01-27

ApplicantMie America, Inc.
Decision Date2006-01-27
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MIE - GAMMA CAMERA SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Mie America, Inc.. It received FDA 510(k) clearance on 2006-01-27 under 510(k) number K053086. 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 MIE - GAMMA CAMERA SYSTEMS?

MIE - GAMMA CAMERA SYSTEMS is a medical device that received FDA 510(k) clearance on 2006-01-27. The listed applicant is Mie America, Inc.. The 510(k) number is K053086.

When did MIE - GAMMA CAMERA SYSTEMS receive FDA 510(k) clearance?

MIE - GAMMA CAMERA SYSTEMS received FDA 510(k) clearance on 2006-01-27, under 510(k) number K053086.

Who is the listed applicant for MIE - GAMMA CAMERA SYSTEMS?

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

What is the FDA product code for MIE - GAMMA CAMERA SYSTEMS?

The FDA product code for MIE - GAMMA CAMERA SYSTEMS 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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