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FDA 510(k)

PULSED FLUOROSCOPIC CONTROL MODEL:PF-02

K-Number: K882358 · 1988-10-19

ApplicantU.S. Imaging, Inc.
Decision Date1988-10-19
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PULSED FLUOROSCOPIC CONTROL MODEL:PF-02 is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Imaging, Inc.. It received FDA 510(k) clearance on 1988-10-19 under 510(k) number K882358. 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 PULSED FLUOROSCOPIC CONTROL MODEL:PF-02?

PULSED FLUOROSCOPIC CONTROL MODEL:PF-02 is a medical device that received FDA 510(k) clearance on 1988-10-19. The listed applicant is U.S. Imaging, Inc.. The 510(k) number is K882358.

When did PULSED FLUOROSCOPIC CONTROL MODEL:PF-02 receive FDA 510(k) clearance?

PULSED FLUOROSCOPIC CONTROL MODEL:PF-02 received FDA 510(k) clearance on 1988-10-19, under 510(k) number K882358.

Who is the listed applicant for PULSED FLUOROSCOPIC CONTROL MODEL:PF-02?

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

What is the FDA product code for PULSED FLUOROSCOPIC CONTROL MODEL:PF-02?

The FDA product code for PULSED FLUOROSCOPIC CONTROL MODEL:PF-02 is IZI.

Related Clinical Trials

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Other records listing U.S. Imaging, 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.

K900062U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROLK890878PHOTOMULITPLIER TUBE INTERFACE P.C. BOARDK881886MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L

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

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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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