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)

COLORPOINT OR PROFESSIONAL COLORPOINT

K-Number: K971760 · 1997-10-01

ApplicantSeiko Instruments USA, Inc.
Decision Date1997-10-01
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COLORPOINT OR PROFESSIONAL COLORPOINT is the device name listed in this FDA 510(k) record. The listed applicant is Seiko Instruments USA, Inc.. It received FDA 510(k) clearance on 1997-10-01 under 510(k) number K971760. 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 COLORPOINT OR PROFESSIONAL COLORPOINT?

COLORPOINT OR PROFESSIONAL COLORPOINT is a medical device that received FDA 510(k) clearance on 1997-10-01. The listed applicant is Seiko Instruments USA, Inc.. The 510(k) number is K971760.

When did COLORPOINT OR PROFESSIONAL COLORPOINT receive FDA 510(k) clearance?

COLORPOINT OR PROFESSIONAL COLORPOINT received FDA 510(k) clearance on 1997-10-01, under 510(k) number K971760.

Who is the listed applicant for COLORPOINT OR PROFESSIONAL COLORPOINT?

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

What is the FDA product code for COLORPOINT OR PROFESSIONAL COLORPOINT?

The FDA product code for COLORPOINT OR PROFESSIONAL COLORPOINT 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 Seiko Instruments USA, 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.

K991282COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES

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.

↑