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FDA 510(k)

SOPHY NXT

K-Number: K913641 · 1991-12-17

ApplicantSopha Medical Systems, Inc.
Decision Date1991-12-17
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOPHY NXT is the device name listed in this FDA 510(k) record. The listed applicant is Sopha Medical Systems, Inc.. It received FDA 510(k) clearance on 1991-12-17 under 510(k) number K913641. 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 SOPHY NXT?

SOPHY NXT is a medical device that received FDA 510(k) clearance on 1991-12-17. The listed applicant is Sopha Medical Systems, Inc.. The 510(k) number is K913641.

When did SOPHY NXT receive FDA 510(k) clearance?

SOPHY NXT received FDA 510(k) clearance on 1991-12-17, under 510(k) number K913641.

Who is the listed applicant for SOPHY NXT?

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

What is the FDA product code for SOPHY NXT?

The FDA product code for SOPHY NXT is KPS.

Related Clinical Trials

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.

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Other records listing Sopha Medical Systems, 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.

K952190TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGEK942837DST-XLK921008VECTOR SERIESK911346SOPHYCAMERA DSX BODYTRAKK894931SOPHYCAMERA DSX RECTANGULARK872132SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS

View all 8 devices →

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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