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FDA 510(k)

POLYSCAN DIGITAL SCANNER

K-Number: K944684 · 1995-05-15

ApplicantMse Medizintechnik GmbH & Co. KG
Decision Date1995-05-15
Product CodeIYW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

POLYSCAN DIGITAL SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Mse Medizintechnik GmbH & Co. KG. It received FDA 510(k) clearance on 1995-05-15 under 510(k) number K944684. The device is classified under product code IYW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYSCAN DIGITAL SCANNER?

POLYSCAN DIGITAL SCANNER is a medical device that received FDA 510(k) clearance on 1995-05-15. The listed applicant is Mse Medizintechnik GmbH & Co. KG. The 510(k) number is K944684.

When did POLYSCAN DIGITAL SCANNER receive FDA 510(k) clearance?

POLYSCAN DIGITAL SCANNER received FDA 510(k) clearance on 1995-05-15, under 510(k) number K944684.

Who is the listed applicant for POLYSCAN DIGITAL SCANNER?

The FDA 510(k) record lists Mse Medizintechnik GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYSCAN DIGITAL SCANNER?

The FDA product code for POLYSCAN DIGITAL SCANNER is IYW.

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: IYW)

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.

K895799RECTILINEAR SCANNER MODEL #187-270Atomic Products Corp.K882453POLYSCAN DIGITAL SCANNERMedical and Scientific Enterprises, Inc.K780395IMAGER, BODY SECTION, RADIONUCLIDEUnion Carbide Corp.

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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