Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008007310

FEI Number

3008007310

Entity Name

Spectrum Dynamics Medical Inc.

City/State/Country

Sarasota, FL, US

Establishment Address

301 N. Cattlemen Rd. Suite 109, Sarasota, FL 34232, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Spectrum Dynamics Medical, Inc. (Owner Number: 10044466)

Owner / Operator Contact Address

301 N. Cattlemen Rd. Suite 109, Sarasota, FL 34232, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230600

PMA Number

N/A

All Registered Proprietary Names

TruSPECT VERITON 200 D-SPECT CARDIO, D-SPECT VISTA VERITON CT 64, VERITON CT 264 VERITON CT 300 Series (VERITON CT 316/364) VERITON CT 400 Series (VERITON CT 316/416)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2022-12-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-12-20
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2018-07-26
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2017-10-26
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-11-18
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2018-11-18
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-12-28
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2023-12-28

Official Correspondent

Jim Haisler

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spectrum Dynamics Medical, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K242270	Orthofix Srl	OrthoNext Platform System	2024-12-19
K261713	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.6.0)	2026-06-18
K243647	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.5)	2025-06-30
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008007310. Last updated year: 2026. Please use registration number 3008007310 when referencing this establishment in official correspondence.