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FDA 510(k)

NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER

K-Number: K090553 · 2009-03-31

ApplicantNaviscan, Inc.
Decision Date2009-03-31
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Naviscan, Inc.. It received FDA 510(k) clearance on 2009-03-31 under 510(k) number K090553. 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 NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER?

NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER is a medical device that received FDA 510(k) clearance on 2009-03-31. The listed applicant is Naviscan, Inc.. The 510(k) number is K090553.

When did NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER receive FDA 510(k) clearance?

NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER received FDA 510(k) clearance on 2009-03-31, under 510(k) number K090553.

Who is the listed applicant for NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER?

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

What is the FDA product code for NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER?

The FDA product code for NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER 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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