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FDA 510(k)

DOT-A, DOT-AR PXP-E, PXP-ER

K-Number: K841905 · 1984-08-09

ApplicantSiemens Gammasonics, Inc.
Decision Date1984-08-09
Product CodeJWM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DOT-A, DOT-AR PXP-E, PXP-ER 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 1984-08-09 under 510(k) number K841905. 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 DOT-A, DOT-AR PXP-E, PXP-ER?

DOT-A, DOT-AR PXP-E, PXP-ER is a medical device that received FDA 510(k) clearance on 1984-08-09. The listed applicant is Siemens Gammasonics, Inc.. The 510(k) number is K841905.

When did DOT-A, DOT-AR PXP-E, PXP-ER receive FDA 510(k) clearance?

DOT-A, DOT-AR PXP-E, PXP-ER received FDA 510(k) clearance on 1984-08-09, under 510(k) number K841905.

Who is the listed applicant for DOT-A, DOT-AR PXP-E, PXP-ER?

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 DOT-A, DOT-AR PXP-E, PXP-ER?

The FDA product code for DOT-A, DOT-AR PXP-E, PXP-ER is JWM.

Other records listing Siemens Gammasonics, Inc. as applicant

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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.K903315ICONSiemens Gammasonics, 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 Laboratories

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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