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FDA 510(k)

GAMMA GUIDANCE SYSTEM

K-Number: K961321 · 1997-02-10

ApplicantRadiation Monitoring Devices, Inc.
Decision Date1997-02-10
Product CodeIZD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GAMMA GUIDANCE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Radiation Monitoring Devices, Inc.. It received FDA 510(k) clearance on 1997-02-10 under 510(k) number K961321. 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 GAMMA GUIDANCE SYSTEM?

GAMMA GUIDANCE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-02-10. The listed applicant is Radiation Monitoring Devices, Inc.. The 510(k) number is K961321.

When did GAMMA GUIDANCE SYSTEM receive FDA 510(k) clearance?

GAMMA GUIDANCE SYSTEM received FDA 510(k) clearance on 1997-02-10, under 510(k) number K961321.

Who is the listed applicant for GAMMA GUIDANCE SYSTEM?

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

What is the FDA product code for GAMMA GUIDANCE SYSTEM?

The FDA product code for GAMMA GUIDANCE SYSTEM is IZD.

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 Radiation Monitoring Devices, 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.

K983768MODIFICATION TO GAMMA GUIDANCE SYSTEM

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 GmbHK013751HANDHELD GAMMA FINDER (HGF)Silicon Instruments GmhbK983768MODIFICATION 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.

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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