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FDA 510(k)

INTRASCAN II

K-Number: K944771 · 1995-01-26

ApplicantMarkcare Medical Systems, Inc.
Decision Date1995-01-26
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTRASCAN II is the device name listed in this FDA 510(k) record. The listed applicant is Markcare Medical Systems, Inc.. It received FDA 510(k) clearance on 1995-01-26 under 510(k) number K944771. The device is classified under product code LMD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRASCAN II?

INTRASCAN II is a medical device that received FDA 510(k) clearance on 1995-01-26. The listed applicant is Markcare Medical Systems, Inc.. The 510(k) number is K944771.

When did INTRASCAN II receive FDA 510(k) clearance?

INTRASCAN II received FDA 510(k) clearance on 1995-01-26, under 510(k) number K944771.

Who is the listed applicant for INTRASCAN II?

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

What is the FDA product code for INTRASCAN II?

The FDA product code for INTRASCAN II is LMD.

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 Markcare Medical Systems, 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.

K934311INTRASCAN(R) MINI-PACS

Related Devices (Code: LMD)

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.

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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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