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)

DRYSTAR, MODEL 4500M

K-Number: K012941 · 2001-11-29

ApplicantAgfa Corp.
Decision Date2001-11-29
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DRYSTAR, MODEL 4500M is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Corp.. It received FDA 510(k) clearance on 2001-11-29 under 510(k) number K012941. 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 DRYSTAR, MODEL 4500M?

DRYSTAR, MODEL 4500M is a medical device that received FDA 510(k) clearance on 2001-11-29. The listed applicant is Agfa Corp.. The 510(k) number is K012941.

When did DRYSTAR, MODEL 4500M receive FDA 510(k) clearance?

DRYSTAR, MODEL 4500M received FDA 510(k) clearance on 2001-11-29, under 510(k) number K012941.

Who is the listed applicant for DRYSTAR, MODEL 4500M?

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

What is the FDA product code for DRYSTAR, MODEL 4500M?

The FDA product code for DRYSTAR, MODEL 4500M 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 Agfa Corp. 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.

K063421DX-SIK053458WEB1000K050810AGFA CR50.0K050751IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.XK042779RADIOTHERAPY SOLUTION BASED ON CRK041701AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM

View all 19 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.

↑