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FDA 510(k)

DIGISPOT IMAGER

K-Number: K871778 · 1987-05-29

ApplicantSiemens Gammasonics, Inc.
Decision Date1987-05-29
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGISPOT IMAGER is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Gammasonics, Inc.. It received FDA 510(k) clearance on 1987-05-29 under 510(k) number K871778. The device is classified under product code LMC. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGISPOT IMAGER?

DIGISPOT IMAGER is a medical device that received FDA 510(k) clearance on 1987-05-29. The listed applicant is Siemens Gammasonics, Inc.. The 510(k) number is K871778.

When did DIGISPOT IMAGER receive FDA 510(k) clearance?

DIGISPOT IMAGER received FDA 510(k) clearance on 1987-05-29, under 510(k) number K871778.

Who is the listed applicant for DIGISPOT IMAGER?

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

What is the FDA product code for DIGISPOT IMAGER?

The FDA product code for DIGISPOT IMAGER is LMC.

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Other records listing Siemens Gammasonics, Inc. as applicant

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Related Devices (Code: LMC)

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K111566DRYVIEW CHROMA IMAGING SYSTEMCarestream Health, Inc.K092280CYPHER DICOM PRINT SOLUTIONVirtual Imaging, Inc.K090469CARESTREAM DRYVIEW 5850 LASER IMAGERCarestream Health, Inc.K083522SONY UP-DF750 DIGITAL FILM IMAGERSony Electronics, Inc.K081637LASER IMAGER DRYPRO MODEL 873Konica Minolta Medical & Graphic, Inc.K072680DRYSTAR AXYS, MODEL EYZ4EAgfa Healthcare Corporation

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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