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FDA 510(k)

NUCAMMA R+

K-Number: K982044 · 1998-09-02

ApplicantIs2 Research, Inc.
Decision Date1998-09-02
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NUCAMMA R+ is the device name listed in this FDA 510(k) record. The listed applicant is Is2 Research, Inc.. It received FDA 510(k) clearance on 1998-09-02 under 510(k) number K982044. 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 NUCAMMA R+?

NUCAMMA R+ is a medical device that received FDA 510(k) clearance on 1998-09-02. The listed applicant is Is2 Research, Inc.. The 510(k) number is K982044.

When did NUCAMMA R+ receive FDA 510(k) clearance?

NUCAMMA R+ received FDA 510(k) clearance on 1998-09-02, under 510(k) number K982044.

Who is the listed applicant for NUCAMMA R+?

The FDA 510(k) record lists Is2 Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NUCAMMA R+?

The FDA product code for NUCAMMA R+ is KPS.

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Other records listing Is2 Research, 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.

K040057MOBILE COMPACT DIGITAL CARDIAC CAMERAK033956MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)K032779MODIFICATION TO: NUCAMMA RXK013667BCC GAMMA CAMERAK003882NUCAMMA BI90K982045NUCAMMA RX

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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

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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