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FDA 510(k)

ELK LASER IMAGER, MODEL EL-DRY 4000

K-Number: K011949 · 2001-08-29

ApplicantNishimoto Sangyo Co., Ltd.
Decision Date2001-08-29
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ELK LASER IMAGER, MODEL EL-DRY 4000 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 2001-08-29 under 510(k) number K011949. 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 ELK LASER IMAGER, MODEL EL-DRY 4000?

ELK LASER IMAGER, MODEL EL-DRY 4000 is a medical device that received FDA 510(k) clearance on 2001-08-29. The listed applicant is Nishimoto Sangyo Co., Ltd.. The 510(k) number is K011949.

When did ELK LASER IMAGER, MODEL EL-DRY 4000 receive FDA 510(k) clearance?

ELK LASER IMAGER, MODEL EL-DRY 4000 received FDA 510(k) clearance on 2001-08-29, under 510(k) number K011949.

Who is the listed applicant for ELK LASER IMAGER, MODEL EL-DRY 4000?

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 IMAGER, MODEL EL-DRY 4000?

The FDA product code for ELK LASER IMAGER, MODEL EL-DRY 4000 is LMC.

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 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.

K984409ELK LASER FILM DIGITIZER

Related Devices (Code: LMC)

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.

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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