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FDA 510(k)

DS DS I-SERIES

K-Number: K002553 · 2000-09-15

ApplicantSmv America
Decision Date2000-09-15
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DS DS I-SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Smv America. It received FDA 510(k) clearance on 2000-09-15 under 510(k) number K002553. 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 DS DS I-SERIES?

DS DS I-SERIES is a medical device that received FDA 510(k) clearance on 2000-09-15. The listed applicant is Smv America. The 510(k) number is K002553.

When did DS DS I-SERIES receive FDA 510(k) clearance?

DS DS I-SERIES received FDA 510(k) clearance on 2000-09-15, under 510(k) number K002553.

Who is the listed applicant for DS DS I-SERIES?

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 DS DS I-SERIES?

The FDA product code for DS DS I-SERIES 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 MOCOK003358QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)K001681POSITRACE 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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