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FDA 510(k)

Vereos PET/CT

K-Number: K211764 · 2021-08-06

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2021-08-06
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vereos PET/CT is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2021-08-06 under 510(k) number K211764. 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 Vereos PET/CT?

Vereos PET/CT is a medical device that received FDA 510(k) clearance on 2021-08-06. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K211764.

When did Vereos PET/CT receive FDA 510(k) clearance?

Vereos PET/CT received FDA 510(k) clearance on 2021-08-06, under 510(k) number K211764.

Who is the listed applicant for Vereos PET/CT?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vereos PET/CT?

The FDA product code for Vereos PET/CT is KPS.

Other records listing Philips Medical Systems Nederland B.V. as applicant

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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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