Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1530958

FEI Number

1000639866

Entity Name

CODONICS, INC.

City/State/Country

Middleburg Heights, OH, US

Establishment Address

17991 Englewood Dr, Middleburg Heights, OH 44130, US

Establishment Type(s)

Manufacture Medical Device,Remanufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

CODONICS, INC. (Owner Number: 9026554)

Owner / Operator Contact Address

17991 ENGLEWOOD DR., --, Middleburg Heights, OH 44130, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251352

PMA Number

N/A

All Registered Proprietary Names

Horizon Multimedia Imager Ci Horizon Multimedia Imager G2 Horizon Multimedia Imager GS Horizon Multimedia Imager G1 Horizon Multimedia Long Film XL Safe Waste System (SWS) Spectrophotometer for Pharmaceutical Analysis Virtua C Medical Device Recorder Virtua E Medical Device Recorder Virtua Medical Image Disc Recorder Virtua XR Medical Image Disc Recorder Virtua E Medical Device Recorder Virtua Medical Image Disc Recorder Virtua C Medical Device Recorder Virtua XR Medical Image Disc Recorder Direct Vista Blue Blue Film,Direct Vista Blue-T(DVBT),Direct Vista Blue-5(DVB5) Direct Vista Clear,Direct Vista White Film,Chroma Vista White Film CODONICS SAFE LABELING SYSTEM (SLS) SLS-500i/550i/600i, SLS-500P, SLS-XXX, Point of Care Station (PCS) Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LMC	Camera, Multi Format, Radiological	Radiology	Class 2	892.2040	2007-12-05
LMC	Camera, Multi Format, Radiological	Radiology	Class 2	892.2040	1999-02-19
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2026-03-16
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2014-03-07
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2007-12-14
IWZ	Film, Radiographic	Radiology	Class 1	892.1840	2003-03-18
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2011-02-11
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2025-11-18

Official Correspondent

Vincent Yee

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CODONICS, 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
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26
K252746	Drägerwerk AG Co. Kgaa	Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)	2026-05-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Z-0008-2014	Draeger Medical, Inc.	2	Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.
Z-0009-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Z-0009-2014	GE Healthcare, LLC	2	GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
Z-0010-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland

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3004977335	Siemens Healthineers AG	FORCHHEIM Bavaria, DE
3001722928	FUJIFILM CORPORATION	ASHIGARAKAMI-GUN Kanagawa, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1530958. Last updated year: 2026. Please use registration number 1530958 when referencing this establishment in official correspondence.