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FDA 510(k)

IC-PRO SYSTEM, VERSION 3.1.0.4

K-Number: K082907 · 2008-11-18

ApplicantPaieon, Inc.
Decision Date2008-11-18
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IC-PRO SYSTEM, VERSION 3.1.0.4 is the device name listed in this FDA 510(k) record. The listed applicant is Paieon, Inc.. It received FDA 510(k) clearance on 2008-11-18 under 510(k) number K082907. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IC-PRO SYSTEM, VERSION 3.1.0.4?

IC-PRO SYSTEM, VERSION 3.1.0.4 is a medical device that received FDA 510(k) clearance on 2008-11-18. The listed applicant is Paieon, Inc.. The 510(k) number is K082907.

When did IC-PRO SYSTEM, VERSION 3.1.0.4 receive FDA 510(k) clearance?

IC-PRO SYSTEM, VERSION 3.1.0.4 received FDA 510(k) clearance on 2008-11-18, under 510(k) number K082907.

Who is the listed applicant for IC-PRO SYSTEM, VERSION 3.1.0.4?

The FDA 510(k) record lists Paieon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IC-PRO SYSTEM, VERSION 3.1.0.4?

The FDA product code for IC-PRO SYSTEM, VERSION 3.1.0.4 is IZI.

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Other records listing Paieon, 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.

K120282CARDNAVK113594C-THV SYSTEMK110256THE IC-PRO SYSTEMK083745THE IC-PRO SYSTEM, MODEL VERSION 3.2K073328CARDIOP-B SYSTEM, VERSION 2.1 WITH LVAK072591CARDIOP-B SYSTEM, VERSION 2.1

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Related Devices (Code: IZI)

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

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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