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FDA 510(k)

SCEPTREP3 PET/CT

K-Number: K042428 · 2004-09-17

ApplicantHitachi Medical Systems America, Inc.
Decision Date2004-09-17
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SCEPTREP3 PET/CT is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2004-09-17 under 510(k) number K042428. 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 SCEPTREP3 PET/CT?

SCEPTREP3 PET/CT is a medical device that received FDA 510(k) clearance on 2004-09-17. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K042428.

When did SCEPTREP3 PET/CT receive FDA 510(k) clearance?

SCEPTREP3 PET/CT received FDA 510(k) clearance on 2004-09-17, under 510(k) number K042428.

Who is the listed applicant for SCEPTREP3 PET/CT?

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

What is the FDA product code for SCEPTREP3 PET/CT?

The FDA product code for SCEPTREP3 PET/CT is KPS.

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Other records listing Hitachi Medical Systems America, 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.

K163528HITACHI Supria Whole-body X-ray CT System Phase 3K162079TRILLIUM Oval Head Coil 32K161748SUPRIA w/guideShot OptionK160152Trillium Oval V 5.1 MRI SystemK153547ECHELON Oval V 5.1 MRI SystemK123509SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM

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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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