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FDA 510(k)

CASS SYSTEM

K-Number: K894263 · 1989-09-01

ApplicantMedical Instrumentation & Diagnostics Corp.(Midco)
Decision Date1989-09-01
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CASS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Instrumentation & Diagnostics Corp.(Midco). It received FDA 510(k) clearance on 1989-09-01 under 510(k) number K894263. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CASS SYSTEM?

CASS SYSTEM is a medical device that received FDA 510(k) clearance on 1989-09-01. The listed applicant is Medical Instrumentation & Diagnostics Corp.(Midco). The 510(k) number is K894263.

When did CASS SYSTEM receive FDA 510(k) clearance?

CASS SYSTEM received FDA 510(k) clearance on 1989-09-01, under 510(k) number K894263.

Who is the listed applicant for CASS SYSTEM?

The FDA 510(k) record lists Medical Instrumentation & Diagnostics Corp.(Midco) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CASS SYSTEM?

The FDA product code for CASS SYSTEM is HAW.

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 Medical Instrumentation & Diagnostics Corp.(Midco) 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.

K991336BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPYK961484CASS SYSTEM (MODIFICATION)K921740COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIEDK911750COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIEDK902488MODIFIED CASS SYSTEM

Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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