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The Codonics Safe Label System (SLS) and SLS Software provides a simple computerbased bar code scanning & printing system to automatically verify drug identity from NDC and other drug vial UDI Barcodes, and to print labels for prepared drugs and other items in use on patients during surgical procedures. Codonics Safe Label System (SLS) is generally placed in, however not limited to, the perioperative environment to identify syringes prepared for anesthesiology use during surgery. Additional uses include producing labels for IVs and other artifacts used during a surgical procedure. SLS can also be used to print "non-surgical environment" color & text labels as required. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians

Codonics Safe Labeling System is a simple, integrated system utilizing a bar code scanner to read and confirm drug identity from NDC and other drug ID Barcodes from vials automatically print labels for prepared drugs and other items in use on patients during surgical procedures. The labels are compliant with national regulations focused on improving medication safety in the perioperative environment. The software components provide functions for scanning vials, creating, indexing, and approved hospital managed promotion of a formulary database, displaying on screen and audibly confirming drug type, printing color The Joint Commission ISO and ASTM compliant labels with 2-D barcodes. The system reads drug vial barcodes and produces waterproof, color labels. The system can be integrated to function with AIMS system workflow to provide real-time documentation of drug administration when the syringe "2D Barcode" is read. Codonics Safe Labeling System consists of : - PC (x86 Pico-ITX based w/on-board RAM) with Ethernet interface . - . SSD/Flash disk - Touch screen end-user interface (for configuring and controlling authorized users, . barcode scan and print jobs, selection of label type and manual/automatic label production % dilution factor indication) - Barcode scanner/decoder . - Label printing engine . - Medical grade (EN60601-1) compliant power supply . Software to support primary functions: - Linux OS for CPU, I/O (USB, IDE or SATA, AUDIO, Network (Ethernet/WIFI), SSD . Disk access, and Touch Screen LCD display - Specific Drivers for Touch Screen LCD, Ink Jet label printer, Barcode scanner, . Ethernet/WIFI communications - NDC or other UDI (Unique Drug Identifier, commonly known in the US as an "NDC") . drug formulary persistent repository (or database) via SSD/USB Flash In addition to these primary functions, there are other functions that are provided by the software, to include: - System configuration (network, security, profiles, etc.) . - Security management to perform accounting and authentication of user data; add . users to the User Database when requested and verify that any authenticating user credentials are correct - Settings management global component available to all other components in the . application; lookup configuration values given the appropriate configuration key - User feedback (job and device status, errors, etc.) various events that describe the . current state of the system are generated - Job function application managers. Each manager is responsible for a specific set of . functionality grouped by a logical theme. For example, the Label Manager handles creating labels based on a set of Label Parameters, the Security Manager handles all issues relating to user management and authentication, and the Print Manager sends commands to and receives responses from the printer hardware Software Application Description: The software scans user Identification (authentication) and drugs by means of a bar code, and identifies connected devices (printers, computer, and barcode scanner, etc.). The software allows a label to be printed which has a color or colors identifying the type of drug contained in the syringe, the name of the drug or drugs, the units of the drug or drugs, the amount of the drug or drugs, total volume of the syringe, the user ID of the preparer, the time and date of the preparation, and a bar code identifying the contents of the syringe. The software also enables the clinician to document the administration of the drug or drugs by reading the bar code printed on the label and transmitting the drug identification to a third party application (i.e. AIMS system). The system also allows for the labeling of drugs which are combined with other drugs or are diluted. Finally, the software also allows the printing of blank labels, with just the clinician's ID and the data/time. The major characteristics and functions of the family of devices include: - Scanning the FDA required drug vial barcode directly from the vial . - Decoding the manufacturer issued barcode into the required FDA national drug code o (NDC) or Unique Drug Identifier (UDI) number - Referring the NDC/UDI number to a site managed formulary lookup database . - Providing audio and ISO-compliant visual "readback" of the drug name . - Providing a clinical alert if the drug vial is listed as recalled in the site formulary . - Printing an easy to read, waterproof ISO 26825 compliant color label meeting The . Joint Commission medication management standards and the American Society of Anesthesiologists guidelines for labeling - Including on same label a printed barcode compliant with national standards for . machine readability allowing integration with an anesthesia information management system (AIMS) - Providing the basic information by which the printed label barcode can be read to . document medication administration in an AIMS system - Providing a 2D barcode of information to permit integration with AIMS systems with . potential for alerts if the prepared drug has expired based on preparation time and site specific drug use criteria - Printing labels with insertion and expiration date and time for IV lines .

The intended uses of the Horizon XL are identical to the Codonics Horizon® Series Medical Hardcopy Dry Imagers (premarket notification K021054); high resolution hard copy imaging of digital image source material combining color, film, reflective media in one imager. The hardcopy output includes however is not limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR and Radiation Therapy planning. Images are suitable for medical image diagnosis use and referral. The system is intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians. The addition of 14" x 36" and 14" x 51" true size "long" film and (TBD) reflective Direct Vista Paper media permits digital direct orthopaedic application hardcopy including diagnosis and analysis of scoliosis, weight bearing spine/hip/knee, and long bone/hip Prosthetic and orthopedic appliances work-up and surgical planning. Horizon XL is applicable to true-size hardcopy of whole body CT, MRI and Angiographic and Venous flow imaging procedures.

The Horizon® Series Imagers are dry, thermal, grey scale and grev scale/color (Ci model) direct thermal printer/imagers. The devices produce continuous tone, diagnostic quality BM images on transmissive film and reflective incident light viewed media. The color images produced via dye-diffusion technology are photographic medical color matched quality. The Horizon® XL provides the capability to image True Size Long films used in Orthopedic applications, particularly in spine and long bone studies. These have been traditionally performed utilizing contact-screen film radiography utilizing special long, light-sensitive x-ray films in special long film/screen cassettes. As more imaging departments and centers become committed to PACS implementation and the application of digital radiography (CR and DR) acquisition, Horizon® XL brings long films into the all-digital world.

The intended uses of the NP-2600 Series Imagers is high resolution hard copy imaging of digital image source material and through the conversion of electronic signals from a wide variety of direct/indirect medical imaging modality outputs. The hardcopy output includes however is not limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR and Radiation Therapy planning; however, does not include digital mammography hardcopy. Images are suitable for medical image diagnosis use and referral. The system is intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians.

The NP-2600 Series Imagers are dry, thermal, color-only (NP-2600), grayscale only (NP-26xx) and grayscale/color(NP-2660) printer/imagers. The devices produce continuous tone, diagnostic quality BM images on transmissive film and reflective incident-light-viewed media. The color images produced via dye-diffusion technology are photographic quality implementing a "CRT to Image" matching process for medical applications.

The intended uses of the EP-1000 Imagers is high resolution hard copy imaging of digital image source material and through the conversion of electronic signals from a wide variety of direct/indirect medical imaging modality outputs. The hardcopy output includes however is not limited to, nuclear medicine, ultrasound, CT (especially 3-D reconstruction), MRI, and Radiation Therapy planning. Images are suitable for medical image diagnosis use and referral. The system is intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians. The intended uses are identical to the Codonics NP-1600 Series Medical Printers (Premarket notification K962364) as a color, reflective media imager. The intended uses are identical to the Seiko ColorPoint 1720 (Premarket notification K991282) in terms of color, reflective media output.

The EP-1000 Imagers are dry, thermal, color printer/imagers. The devices produce continuous tone, diagnostic quality B/W and color images on reflective, incident light viewed media. The images produced via dye-diffusion technology are photographic and medical color matched quality. Digital images are input directly to industry standard parallel (IEEE 1284) or Universal Serial Bus (USB 1.1) interfaces. The EP-1000 recognizes only its own proprietary image format which employs a 24-bit, RGB encoding for each pixel to be printed. Lossy data compression is not employed. Software drivers can be written or adapted for a plurality of host imaging applications and operating systems, which can translate image data of any format to the EP-1000 format. The EP-1000 does not process or alter the received image data in any way. Host imaging applications or drivers can be designed to pre-compensate image data with gamma, contrast, rotation, scaling, etc; but the EP-1000 can only print the image data as received. Imaging is accomplished via directly-modulated discrete-element thin-layer linear thermal print head technology. The recording medium is heat activated dye-diffusion of color onto photographic quality ChromaVista paper. The image formation is accomplished without wet chemistry processing common to many laser film imaging systems in use today.

The intended uses of the Horizon® Series Imagers is high resolution hard copy imaging of digital image source material and through the conversion of electronic signals from a wide variety of direct/indirect medical imaging modality outputs. The hardcopy output includes however is not limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR and Radiation Therapy planning. Images are suitable for medical image diagnosis use and referral. The system is intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians.

The Horizon® Series Imagers are dry, thermal, grey scale (Gs model) and grey scale/color (Ci model) direct thermal printer/imagers. The devices produce continuous tone, diagnostic quality B/W images on transmissive film and reflective incident light viewed media. The color images produced via dye-diffusion technology are photographic medical color matched quality.

The primary intended use of this device is to create hard copy prints or transparencies of medical images acquired from computer networks typically used in a medical environment.

Codonics NP-1600M and NP-1600MD Medical Color Printer produces continuous photographic quality hard copies of electronically created or stored images.