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FDA 510(k)

3D-MSPECT

K-Number: K980867 · 1998-06-04

ApplicantAdac Laboratories
Decision Date1998-06-04
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3D-MSPECT is the device name listed in this FDA 510(k) record. The listed applicant is Adac Laboratories. It received FDA 510(k) clearance on 1998-06-04 under 510(k) number K980867. 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 3D-MSPECT?

3D-MSPECT is a medical device that received FDA 510(k) clearance on 1998-06-04. The listed applicant is Adac Laboratories. The 510(k) number is K980867.

When did 3D-MSPECT receive FDA 510(k) clearance?

3D-MSPECT received FDA 510(k) clearance on 1998-06-04, under 510(k) number K980867.

Who is the listed applicant for 3D-MSPECT?

The FDA 510(k) record lists Adac Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3D-MSPECT?

The FDA product code for 3D-MSPECT is KPS.

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Other records listing Adac Laboratories 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.

K062298APOLLO GAMMA CAMERA SYSTEMK061029JETSTREAM WORKSPACEK060020AUTOQUANT PLUSK051351PRECEDENCE SPECT/CT IMAGING SYSTEMK042880JETSTREAM WORKSPACEK042903AUTOSPECS

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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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