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FDA 510(k)

BP-SPECT V1.O

K-Number: K042258 · 2004-10-04

ApplicantSyntermed, Inc.
Decision Date2004-10-04
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BP-SPECT V1.O is the device name listed in this FDA 510(k) record. The listed applicant is Syntermed, Inc.. It received FDA 510(k) clearance on 2004-10-04 under 510(k) number K042258. 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 BP-SPECT V1.O?

BP-SPECT V1.O is a medical device that received FDA 510(k) clearance on 2004-10-04. The listed applicant is Syntermed, Inc.. The 510(k) number is K042258.

When did BP-SPECT V1.O receive FDA 510(k) clearance?

BP-SPECT V1.O received FDA 510(k) clearance on 2004-10-04, under 510(k) number K042258.

Who is the listed applicant for BP-SPECT V1.O?

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

What is the FDA product code for BP-SPECT V1.O?

The FDA product code for BP-SPECT V1.O is KPS.

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Other records listing Syntermed, 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.

K130902EMORY CARDIAC TOOLBOX 3.2K130451NEUROQ 3.6K123646EMORY CARDIAC TOOLBOX 4.0K072307QUANTITATIVE NEUROQ 3.0K071503SYSTEM, TOMOGRAPHY, COMPUTED EMISSIONK070089SYNTERMED LIVE

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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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