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FDA 510(k)

INTRASCAN(R) MINI-PACS

K-Number: K934311 · 1993-12-13

ApplicantMarkcare Medical Systems, Inc.
Decision Date1993-12-13
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTRASCAN(R) MINI-PACS 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 1993-12-13 under 510(k) number K934311. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRASCAN(R) MINI-PACS?

INTRASCAN(R) MINI-PACS is a medical device that received FDA 510(k) clearance on 1993-12-13. The listed applicant is Markcare Medical Systems, Inc.. The 510(k) number is K934311.

When did INTRASCAN(R) MINI-PACS receive FDA 510(k) clearance?

INTRASCAN(R) MINI-PACS received FDA 510(k) clearance on 1993-12-13, under 510(k) number K934311.

Who is the listed applicant for INTRASCAN(R) MINI-PACS?

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(R) MINI-PACS?

The FDA product code for INTRASCAN(R) MINI-PACS is IYO.

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.

K944771INTRASCAN II

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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.

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