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FDA 510(k)

PROWESS PRO-SIM

K-Number: K980379 · 1998-05-18

ApplicantSsgi Prowess Systems
Decision Date1998-05-18
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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 1998-05-18 under 510(k) number K980379. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROWESS PRO-SIM?

PROWESS PRO-SIM is a medical device that received FDA 510(k) clearance on 1998-05-18. The listed applicant is Ssgi Prowess Systems. The 510(k) number is K980379.

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

PROWESS PRO-SIM received FDA 510(k) clearance on 1998-05-18, under 510(k) number K980379.

Who is the listed applicant for 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 PROWESS PRO-SIM?

The FDA product code for PROWESS PRO-SIM is IYE.

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.

K984196MODIFICATION TO PROWESS PRO-SIM

Related Devices (Code: IYE)

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.

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLCK261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser Applikationen

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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