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FDA 510(k)

MODIFICATION TO: NUCAMMA RX

K-Number: K032779 · 2003-12-17

ApplicantIs2 Research, Inc.
Decision Date2003-12-17
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: NUCAMMA RX 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 2003-12-17 under 510(k) number K032779. 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 MODIFICATION TO: NUCAMMA RX?

MODIFICATION TO: NUCAMMA RX is a medical device that received FDA 510(k) clearance on 2003-12-17. The listed applicant is Is2 Research, Inc.. The 510(k) number is K032779.

When did MODIFICATION TO: NUCAMMA RX receive FDA 510(k) clearance?

MODIFICATION TO: NUCAMMA RX received FDA 510(k) clearance on 2003-12-17, under 510(k) number K032779.

Who is the listed applicant for MODIFICATION TO: NUCAMMA RX?

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 MODIFICATION TO: NUCAMMA RX?

The FDA product code for MODIFICATION TO: NUCAMMA RX 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)K013667BCC GAMMA CAMERAK003882NUCAMMA BI90K982045NUCAMMA RXK982044NUCAMMA R+

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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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