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FDA 510(k)

C-QUEST

K-Number: K082581 · 2008-11-14

ApplicantMedx, Inc.
Decision Date2008-11-14
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

C-QUEST is the device name listed in this FDA 510(k) record. The listed applicant is Medx, Inc.. It received FDA 510(k) clearance on 2008-11-14 under 510(k) number K082581. 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 C-QUEST?

C-QUEST is a medical device that received FDA 510(k) clearance on 2008-11-14. The listed applicant is Medx, Inc.. The 510(k) number is K082581.

When did C-QUEST receive FDA 510(k) clearance?

C-QUEST received FDA 510(k) clearance on 2008-11-14, under 510(k) number K082581.

Who is the listed applicant for C-QUEST?

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

What is the FDA product code for C-QUEST?

The FDA product code for C-QUEST is KPS.

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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.

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Other records listing Medx, Inc. 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.

K073456T-QUEST SYSTEMK041840MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEMK012953GIOTTO IMAGEK993893MEDX INTECAM INTERFACEK884661D-SCOPE IIIK872127D-SCOPE II AND D-SCOPE IIC

View all 8 devices →

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

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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