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 4500 PRINTER, MODEL 4500

K-Number: K010275 · 2001-04-27

ApplicantAgfa Medical Imaging
Decision Date2001-04-27
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DRYSTAR 4500 PRINTER, MODEL 4500 is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Medical Imaging. It received FDA 510(k) clearance on 2001-04-27 under 510(k) number K010275. 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 4500 PRINTER, MODEL 4500?

DRYSTAR 4500 PRINTER, MODEL 4500 is a medical device that received FDA 510(k) clearance on 2001-04-27. The listed applicant is Agfa Medical Imaging. The 510(k) number is K010275.

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

DRYSTAR 4500 PRINTER, MODEL 4500 received FDA 510(k) clearance on 2001-04-27, under 510(k) number K010275.

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

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

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

The FDA product code for DRYSTAR 4500 PRINTER, MODEL 4500 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

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.

↑