Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM

K-Number: K892342 · 1989-11-17

ApplicantBay Shore Medical Equipment Corp.
Decision Date1989-11-17
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bay Shore Medical Equipment Corp.. It received FDA 510(k) clearance on 1989-11-17 under 510(k) number K892342. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM?

TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM is a medical device that received FDA 510(k) clearance on 1989-11-17. The listed applicant is Bay Shore Medical Equipment Corp.. The 510(k) number is K892342.

When did TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM receive FDA 510(k) clearance?

TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM received FDA 510(k) clearance on 1989-11-17, under 510(k) number K892342.

Who is the listed applicant for TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM?

The FDA 510(k) record lists Bay Shore Medical Equipment Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM?

The FDA product code for TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM is IZH.

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 Bay Shore Medical Equipment Corp. 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.

K922814TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICATK904397TEC 1410

Related Devices (Code: IZH)

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.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm CorporationK161575Affirm Lateral Arm Upright Biopsy AccessoryHologicK161920Comfort CoverPrecision Dynamics CorporationK153486Affirm Prone Biopsy SystemHologic, 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.

↑