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FDA 510(k)

ELK LASER FILM DIGITIZER

K-Number: K984409 · 1999-02-12

ApplicantNishimoto Sangyo Co., Ltd.
Decision Date1999-02-12
Product CodeLMA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ELK LASER FILM DIGITIZER is the device name listed in this FDA 510(k) record. The listed applicant is Nishimoto Sangyo Co., Ltd.. It received FDA 510(k) clearance on 1999-02-12 under 510(k) number K984409. The device is classified under product code LMA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELK LASER FILM DIGITIZER?

ELK LASER FILM DIGITIZER is a medical device that received FDA 510(k) clearance on 1999-02-12. The listed applicant is Nishimoto Sangyo Co., Ltd.. The 510(k) number is K984409.

When did ELK LASER FILM DIGITIZER receive FDA 510(k) clearance?

ELK LASER FILM DIGITIZER received FDA 510(k) clearance on 1999-02-12, under 510(k) number K984409.

Who is the listed applicant for ELK LASER FILM DIGITIZER?

The FDA 510(k) record lists Nishimoto Sangyo Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELK LASER FILM DIGITIZER?

The FDA product code for ELK LASER FILM DIGITIZER is LMA.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Nishimoto Sangyo Co., Ltd. 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.

K011949ELK LASER IMAGER, MODEL EL-DRY 4000

Related Devices (Code: LMA)

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.

K132183DICOM VIDEOBar Code Computer, Ltd.K130636TELERADPRO EDGE; TELERADPRO EDGE HD-CCDVidar Systems Corp.K130406DIAGNOSTICPRO EDGEVidar Systems Corp.K102476TELERADPROVidar Systems Corp.K093809VIDAR DENTAL FILM DIGITIZERVidar Systems Corp.K091288MEDI-6000 MEDICAL IMAGE DIGITIZERMicrotek International, Inc.

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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