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FDA 510(k)

VISIONPRO

K-Number: K912177 · 1991-09-06

ApplicantTrionix Research Laboratory, Inc.
Decision Date1991-09-06
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISIONPRO is the device name listed in this FDA 510(k) record. The listed applicant is Trionix Research Laboratory, Inc.. It received FDA 510(k) clearance on 1991-09-06 under 510(k) number K912177. 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 VISIONPRO?

VISIONPRO is a medical device that received FDA 510(k) clearance on 1991-09-06. The listed applicant is Trionix Research Laboratory, Inc.. The 510(k) number is K912177.

When did VISIONPRO receive FDA 510(k) clearance?

VISIONPRO received FDA 510(k) clearance on 1991-09-06, under 510(k) number K912177.

Who is the listed applicant for VISIONPRO?

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

What is the FDA product code for VISIONPRO?

The FDA product code for VISIONPRO is KPS.

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Other records listing Trionix Research Laboratory, 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.

K964438511 KEV COLLIMATORK962481QUASAR RECOVERY IMAGING PACKAGEK964268TRIAD 88 NUCLEAR IMAGING SYSTEMK964265CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEMK964267MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEMK964266BIAD NUCLEAR IMAGING 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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