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FDA 510(k)

QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)

K-Number: K003358 · 2001-01-19

ApplicantSmv America
Decision Date2001-01-19
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT) is the device name listed in this FDA 510(k) record. The listed applicant is Smv America. It received FDA 510(k) clearance on 2001-01-19 under 510(k) number K003358. 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 QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)?

QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT) is a medical device that received FDA 510(k) clearance on 2001-01-19. The listed applicant is Smv America. The 510(k) number is K003358.

When did QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT) receive FDA 510(k) clearance?

QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT) received FDA 510(k) clearance on 2001-01-19, under 510(k) number K003358.

Who is the listed applicant for QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)?

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

What is the FDA product code for QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)?

The FDA product code for QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT) is KPS.

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Other records listing Smv America 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.

K010509CEDARS-SINAI BPGS AND MOCOK002553DS DS I-SERIESK001681POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEMK991565TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN SK972686VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTERK963273VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION

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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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