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FDA 510(k)

Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems

K-Number: K251671 · 2025-07-03

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2025-07-03
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2025-07-03 under 510(k) number K251671. 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 Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems?

Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K251671.

When did Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems receive FDA 510(k) clearance?

Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems received FDA 510(k) clearance on 2025-07-03, under 510(k) number K251671.

Who is the listed applicant for Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems?

The FDA product code for Biograph Vision PET/CT Systems; Biograph mCT PET/CT 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.

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.K253844AnyScan 3.0 NM Scanner FamilyMediso Medical Imaging Systems, 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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