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FDA 510(k)

SP-100-B SMALL PARTS SCANNER SYSTEM

K-Number: K811595 · 1981-08-12

ApplicantHighstoy
Decision Date1981-08-12
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SP-100-B SMALL PARTS SCANNER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Highstoy. It received FDA 510(k) clearance on 1981-08-12 under 510(k) number K811595. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SP-100-B SMALL PARTS SCANNER SYSTEM?

SP-100-B SMALL PARTS SCANNER SYSTEM is a medical device that received FDA 510(k) clearance on 1981-08-12. The listed applicant is Highstoy. The 510(k) number is K811595.

When did SP-100-B SMALL PARTS SCANNER SYSTEM receive FDA 510(k) clearance?

SP-100-B SMALL PARTS SCANNER SYSTEM received FDA 510(k) clearance on 1981-08-12, under 510(k) number K811595.

Who is the listed applicant for SP-100-B SMALL PARTS SCANNER SYSTEM?

The FDA 510(k) record lists Highstoy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SP-100-B SMALL PARTS SCANNER SYSTEM?

The FDA product code for SP-100-B SMALL PARTS SCANNER SYSTEM is DXK.

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 Highstoy 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.

K800850HIGH STOY SMALL PARTS SCANNER #SP-100B

Related Devices (Code: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics 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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