Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY

K-Number: K002146 · 2000-09-27

ApplicantEastman Kodak Company
Decision Date2000-09-27
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY is the device name listed in this FDA 510(k) record. The listed applicant is Eastman Kodak Company. It received FDA 510(k) clearance on 2000-09-27 under 510(k) number K002146. 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 KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY?

KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY is a medical device that received FDA 510(k) clearance on 2000-09-27. The listed applicant is Eastman Kodak Company. The 510(k) number is K002146.

When did KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY receive FDA 510(k) clearance?

KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY received FDA 510(k) clearance on 2000-09-27, under 510(k) number K002146.

Who is the listed applicant for KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY?

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

What is the FDA product code for KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY?

The FDA product code for KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY 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.

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 Eastman Kodak Company 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.

K060550KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386K060137KODAK ECLIPSE IMAGE PROCESSING SOFTWAREK060079KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEMK060055KODAK PACSK053347KODAK CARESTREAM PACSK051483KODAK DIRECTVIEW DR SYSTEM DETECTOR

View all 238 devices →

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.

↑