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FDA 510(k)

ICON

K-Number: K903315 · 1991-01-09

ApplicantSiemens Gammasonics, Inc.
Decision Date1991-01-09
Product CodeJWM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ICON is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Gammasonics, Inc.. It received FDA 510(k) clearance on 1991-01-09 under 510(k) number K903315. The device is classified under product code JWM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICON?

ICON is a medical device that received FDA 510(k) clearance on 1991-01-09. The listed applicant is Siemens Gammasonics, Inc.. The 510(k) number is K903315.

When did ICON receive FDA 510(k) clearance?

ICON received FDA 510(k) clearance on 1991-01-09, under 510(k) number K903315.

Who is the listed applicant for ICON?

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

What is the FDA product code for ICON?

The FDA product code for ICON is JWM.

Other records listing Siemens Gammasonics, 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.

K934766CARBON FIBER PALLETK933664POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)K933256FAN BEAM COLLIMATORK920319SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITIK923582SIENET CAMERA SERVERK922373MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEM

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Related Devices (Code: JWM)

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.

K914350ICON COMPUTER SYSTEMSiemens Gammasonics, Inc.K904599D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEMDigital Design, Inc.K901545GCA-9300 NUCLEAR TOMOGRAPHY SYSTEMToshiba America Medical Systems, In.CK874473ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEMAdac LaboratoriesK873075ADAC MODEL ARC-5000, GAMMA CAMERAAdac LaboratoriesK851685DIGITAL GAMMA CAMERA GCA 601 EToshiba Medical Systems

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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