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FDA 510(k)

DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)

K-Number: K973081 · 1997-11-05

ApplicantHowtek, Inc.
Decision Date1997-11-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) is the device name listed in this FDA 510(k) record. The listed applicant is Howtek, Inc.. It received FDA 510(k) clearance on 1997-11-05 under 510(k) number K973081. 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 DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)?

DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) is a medical device that received FDA 510(k) clearance on 1997-11-05. The listed applicant is Howtek, Inc.. The 510(k) number is K973081.

When did DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) receive FDA 510(k) clearance?

DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) received FDA 510(k) clearance on 1997-11-05, under 510(k) number K973081.

Who is the listed applicant for DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)?

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

What is the FDA product code for DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)?

The FDA product code for DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) 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 Howtek, 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.

K021949FULCRUMK972191DIGITIZER DIRECTOR (HSC025-01)K970908HOWTEK 960K953117SCANMASTER DX

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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