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FDA 510(k)

Hybrid Viewer (00859873006240)

K-Number: K252477 · 2025-09-09

ApplicantHermes Medical Solutions AB
Decision Date2025-09-09
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Hybrid Viewer (00859873006240) is the device name listed in this FDA 510(k) record. The listed applicant is Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2025-09-09 under 510(k) number K252477. 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 Hybrid Viewer (00859873006240)?

Hybrid Viewer (00859873006240) is a medical device that received FDA 510(k) clearance on 2025-09-09. The listed applicant is Hermes Medical Solutions AB. The 510(k) number is K252477.

When did Hybrid Viewer (00859873006240) receive FDA 510(k) clearance?

Hybrid Viewer (00859873006240) received FDA 510(k) clearance on 2025-09-09, under 510(k) number K252477.

Who is the listed applicant for Hybrid Viewer (00859873006240)?

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

What is the FDA product code for Hybrid Viewer (00859873006240)?

The FDA product code for Hybrid Viewer (00859873006240) is KPS.

Other records listing Hermes Medical Solutions AB 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.

K253835AffinityK243919Voxel Dosimetry (00859873006226)K241364Hybrid Viewer (00859873006189)K202882AffinityK193152AffinityK191216Voxel Dosimetry™ v1.0

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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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