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FDA 510(k)

HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4

K-Number: K021656 · 2002-06-13

ApplicantNuclear Diagnostics
Decision Date2002-06-13
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Diagnostics. It received FDA 510(k) clearance on 2002-06-13 under 510(k) number K021656. 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 HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4?

HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 is a medical device that received FDA 510(k) clearance on 2002-06-13. The listed applicant is Nuclear Diagnostics. The 510(k) number is K021656.

When did HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 receive FDA 510(k) clearance?

HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 received FDA 510(k) clearance on 2002-06-13, under 510(k) number K021656.

Who is the listed applicant for HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4?

The FDA 510(k) record lists Nuclear Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4?

The FDA product code for HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 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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