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FDA 510(k)

S9 DISPLAY SYSTEM

K-Number: K874214 · 1988-02-22

ApplicantO.M.I. Oncology Microsystems, Inc.
Decision Date1988-02-22
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

S9 DISPLAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is O.M.I. Oncology Microsystems, Inc.. It received FDA 510(k) clearance on 1988-02-22 under 510(k) number K874214. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S9 DISPLAY SYSTEM?

S9 DISPLAY SYSTEM is a medical device that received FDA 510(k) clearance on 1988-02-22. The listed applicant is O.M.I. Oncology Microsystems, Inc.. The 510(k) number is K874214.

When did S9 DISPLAY SYSTEM receive FDA 510(k) clearance?

S9 DISPLAY SYSTEM received FDA 510(k) clearance on 1988-02-22, under 510(k) number K874214.

Who is the listed applicant for S9 DISPLAY SYSTEM?

The FDA 510(k) record lists O.M.I. Oncology Microsystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S9 DISPLAY SYSTEM?

The FDA product code for S9 DISPLAY SYSTEM is JAD.

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 O.M.I. Oncology Microsystems, 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.

K883101DVS (OPTION 01)

Related Devices (Code: JAD)

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.

K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AGK230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.K213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K182641Sensus IORT SystemSensus Healthcare, 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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