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)

DRYVIEW CHROMA IMAGING SYSTEM

K-Number: K111566 · 2011-10-06

ApplicantCarestream Health, Inc.
Decision Date2011-10-06
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DRYVIEW CHROMA IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2011-10-06 under 510(k) number K111566. 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 DRYVIEW CHROMA IMAGING SYSTEM?

DRYVIEW CHROMA IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-06. The listed applicant is Carestream Health, Inc.. The 510(k) number is K111566.

When did DRYVIEW CHROMA IMAGING SYSTEM receive FDA 510(k) clearance?

DRYVIEW CHROMA IMAGING SYSTEM received FDA 510(k) clearance on 2011-10-06, under 510(k) number K111566.

Who is the listed applicant for DRYVIEW CHROMA IMAGING SYSTEM?

The FDA 510(k) record lists Carestream Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRYVIEW CHROMA IMAGING SYSTEM?

The FDA product code for DRYVIEW CHROMA IMAGING SYSTEM 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 Carestream Health, Inc. 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.

K251168Image SuiteK241505DRX-Revolution Mobile X-ray SystemK233381DRX-Evolution Plus SystemK223842DRX - CompassK213307Eclipse II with Smart Noise CancellationK202441Eclipse II with Smart Noise Cancellation

View all 39 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.

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 CorporationK061999DRY LASER IMAGER, DRYPRO MODEL 832Konica Minolta Medical & Graphic, Inc.

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.

↑