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FDA 510(k)

DRYSTAR MODEL 5500

K-Number: K052251 · 2005-08-31

ApplicantAgfa Corporation
Decision Date2005-08-31
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DRYSTAR MODEL 5500 is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Corporation. It received FDA 510(k) clearance on 2005-08-31 under 510(k) number K052251. 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 5500?

DRYSTAR MODEL 5500 is a medical device that received FDA 510(k) clearance on 2005-08-31. The listed applicant is Agfa Corporation. The 510(k) number is K052251.

When did DRYSTAR MODEL 5500 receive FDA 510(k) clearance?

DRYSTAR MODEL 5500 received FDA 510(k) clearance on 2005-08-31, under 510(k) number K052251.

Who is the listed applicant for DRYSTAR MODEL 5500?

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

What is the FDA product code for DRYSTAR MODEL 5500?

The FDA product code for DRYSTAR MODEL 5500 is LMC.

Related Clinical Trials

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Other records listing Agfa Corporation 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.

K062742CR 85-XK062223AGFA MODEL CR30-XK053634COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION

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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