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FDA 510(k)

HANDHELD GAMMA FINDER (HGF)

K-Number: K013751 · 2002-02-06

ApplicantSilicon Instruments Gmhb
Decision Date2002-02-06
Product CodeIZD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HANDHELD GAMMA FINDER (HGF) is the device name listed in this FDA 510(k) record. The listed applicant is Silicon Instruments Gmhb. It received FDA 510(k) clearance on 2002-02-06 under 510(k) number K013751. The device is classified under product code IZD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDHELD GAMMA FINDER (HGF)?

HANDHELD GAMMA FINDER (HGF) is a medical device that received FDA 510(k) clearance on 2002-02-06. The listed applicant is Silicon Instruments Gmhb. The 510(k) number is K013751.

When did HANDHELD GAMMA FINDER (HGF) receive FDA 510(k) clearance?

HANDHELD GAMMA FINDER (HGF) received FDA 510(k) clearance on 2002-02-06, under 510(k) number K013751.

Who is the listed applicant for HANDHELD GAMMA FINDER (HGF)?

The FDA 510(k) record lists Silicon Instruments Gmhb as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HANDHELD GAMMA FINDER (HGF)?

The FDA product code for HANDHELD GAMMA FINDER (HGF) is IZD.

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Related Devices (Code: IZD)

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.

K123917DECLIPSESPECT VIEWERSurgiceye GmbHK101887CONFIDENT SURGERY SUITE 300, MODEL CSS300Surgiceye GmbHK983768MODIFICATION TO GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, Inc.K982442C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)Care Wise Medical Products Corp.K971167NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESNeoprobe Corp.K961321GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, 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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