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FDA 510(k)

PROCESSING SYSTEM, A2 IMAGE

K-Number: K782047 · 1978-12-20

ApplicantMedtronic Vascular
Decision Date1978-12-20
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROCESSING SYSTEM, A2 IMAGE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1978-12-20 under 510(k) number K782047. 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 PROCESSING SYSTEM, A2 IMAGE?

PROCESSING SYSTEM, A2 IMAGE is a medical device that received FDA 510(k) clearance on 1978-12-20. The listed applicant is Medtronic Vascular. The 510(k) number is K782047.

When did PROCESSING SYSTEM, A2 IMAGE receive FDA 510(k) clearance?

PROCESSING SYSTEM, A2 IMAGE received FDA 510(k) clearance on 1978-12-20, under 510(k) number K782047.

Who is the listed applicant for PROCESSING SYSTEM, A2 IMAGE?

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

What is the FDA product code for PROCESSING SYSTEM, A2 IMAGE?

The FDA product code for PROCESSING SYSTEM, A2 IMAGE is IYX.

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Other records listing Medtronic Vascular as applicant

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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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