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FDA 510(k)

CARDIOFOCAL COLLIMATOR

K-Number: K914179 · 1991-10-30

ApplicantSiemens Gammasonics, Inc.
Decision Date1991-10-30
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIOFOCAL COLLIMATOR 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 1991-10-30 under 510(k) number K914179. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOFOCAL COLLIMATOR?

CARDIOFOCAL COLLIMATOR is a medical device that received FDA 510(k) clearance on 1991-10-30. The listed applicant is Siemens Gammasonics, Inc.. The 510(k) number is K914179.

When did CARDIOFOCAL COLLIMATOR receive FDA 510(k) clearance?

CARDIOFOCAL COLLIMATOR received FDA 510(k) clearance on 1991-10-30, under 510(k) number K914179.

Who is the listed applicant for CARDIOFOCAL COLLIMATOR?

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 CARDIOFOCAL COLLIMATOR?

The FDA product code for CARDIOFOCAL COLLIMATOR is KPS.

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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: KPS)

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.

K261305MICSI-PETMicrostructure Imaging, Inc.K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd.K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 FamilySiemens Medical Solutions USA, Inc.K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)Spectrum Dynamics Medical, Ltd.

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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