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FDA 510(k)

SOPHYCAMERA DSX BODYTRAK

K-Number: K911346 · 1991-04-18

ApplicantSopha Medical Systems, Inc.
Decision Date1991-04-18
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOPHYCAMERA DSX BODYTRAK 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 1991-04-18 under 510(k) number K911346. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOPHYCAMERA DSX BODYTRAK?

SOPHYCAMERA DSX BODYTRAK is a medical device that received FDA 510(k) clearance on 1991-04-18. The listed applicant is Sopha Medical Systems, Inc.. The 510(k) number is K911346.

When did SOPHYCAMERA DSX BODYTRAK receive FDA 510(k) clearance?

SOPHYCAMERA DSX BODYTRAK received FDA 510(k) clearance on 1991-04-18, under 510(k) number K911346.

Who is the listed applicant for SOPHYCAMERA DSX BODYTRAK?

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 SOPHYCAMERA DSX BODYTRAK?

The FDA product code for SOPHYCAMERA DSX BODYTRAK is IYX.

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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 SERIESK913641SOPHY NXTK894931SOPHYCAMERA DSX RECTANGULARK872132SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS

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Related Devices (Code: IYX)

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.

K230221QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)Versant Medical Physics and Radiation SafetyK2125873D-RD-SRadiopharmaceutical Imaging and Dosimetry, LLCK163687OLINDA EXMHermes Medical Solutions ABK160933Discovery NM 750b BopsyGE HealthcareK162052Sentinella 102, Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision-K123408ERGO IMAGING SYSTEMDigirad Corp.

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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