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FDA 510(k)

RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000

K-Number: K853395 · 1985-11-01

ApplicantRaytheon Medical Systems
Decision Date1985-11-01
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Raytheon Medical Systems. It received FDA 510(k) clearance on 1985-11-01 under 510(k) number K853395. 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 RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000?

RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000 is a medical device that received FDA 510(k) clearance on 1985-11-01. The listed applicant is Raytheon Medical Systems. The 510(k) number is K853395.

When did RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000 receive FDA 510(k) clearance?

RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000 received FDA 510(k) clearance on 1985-11-01, under 510(k) number K853395.

Who is the listed applicant for RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000?

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

What is the FDA product code for RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000?

The FDA product code for RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000 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 Raytheon Medical Systems 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.

K851644SPECTRUM 150 DT

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

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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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