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FDA 510(k)

MODIFICATION TO PROWESS PRO-SIM

K-Number: K984196 · 1998-12-11

ApplicantSsgi Prowess Systems
Decision Date1998-12-11
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PROWESS PRO-SIM is the device name listed in this FDA 510(k) record. The listed applicant is Ssgi Prowess Systems. It received FDA 510(k) clearance on 1998-12-11 under 510(k) number K984196. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO PROWESS PRO-SIM?

MODIFICATION TO PROWESS PRO-SIM is a medical device that received FDA 510(k) clearance on 1998-12-11. The listed applicant is Ssgi Prowess Systems. The 510(k) number is K984196.

When did MODIFICATION TO PROWESS PRO-SIM receive FDA 510(k) clearance?

MODIFICATION TO PROWESS PRO-SIM received FDA 510(k) clearance on 1998-12-11, under 510(k) number K984196.

Who is the listed applicant for MODIFICATION TO PROWESS PRO-SIM?

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

What is the FDA product code for MODIFICATION TO PROWESS PRO-SIM?

The FDA product code for MODIFICATION TO PROWESS PRO-SIM is MUJ.

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 Ssgi Prowess 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.

K980379PROWESS PRO-SIM

Related Devices (Code: MUJ)

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.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformaiK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian Medical Systems, 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.

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