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FDA 510(k)

SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF

K-Number: K901422 · 1990-08-21

ApplicantImage Systems, Inc.
Decision Date1990-08-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF is the device name listed in this FDA 510(k) record. The listed applicant is Image Systems, Inc.. It received FDA 510(k) clearance on 1990-08-21 under 510(k) number K901422. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF?

SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF is a medical device that received FDA 510(k) clearance on 1990-08-21. The listed applicant is Image Systems, Inc.. The 510(k) number is K901422.

When did SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF receive FDA 510(k) clearance?

SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF received FDA 510(k) clearance on 1990-08-21, under 510(k) number K901422.

Who is the listed applicant for SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF?

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

What is the FDA product code for SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF?

The FDA product code for SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF is LLZ.

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 Image 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.

K913755STATVIEWK844771INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM

Related Devices (Code: LLZ)

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

Official Source

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