(142 days)
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No
The summary describes a medical printer and does not mention any AI or ML capabilities.
No.
The device's intended use is to create hard copy prints of medical images. It does not perform any therapeutic function, diagnose, or treat any condition.
No
This device is a printer that creates hard copies of medical images. It does not perform any analysis or interpretation of the images to diagnose medical conditions, nor does it generate new information for diagnostic purposes. Its function is to reproduce existing diagnostic images.
No
The device description explicitly states it is a "Medical Color Printer" which is a hardware device that produces hard copies.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to create hard copy prints or transparencies of medical images. This is a function related to image display and documentation, not the analysis of biological samples or the diagnosis of disease based on in vitro testing.
- Device Description: The device is described as a medical color printer that produces hard copies of images. This aligns with image output, not in vitro analysis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory tests.
The device is clearly intended for the output and documentation of medical images, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Codonics NP-1600M and NP-1600MD Medical Color Printer produces continuous photographic quality hard copies of electronically created or stored images. 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.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Codonics NP-1600M and NP-1600MD Medical Color Printer
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Extensive testing of the device has been performed by technical users, by nontechnical users and by potential customers. There is no lossy compression used with this device. Image quality has been verified by radiologists who compared hard copy images printed on the system compared with the original CRT images.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 892.2040 Medical image hardcopy device.
(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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K962364 SUMMARY STATEMENT OF SAFETY NOV - 8 1996 and EFFECTIVENESS
In accordance with the provisions of the Safe Medical Device Act of 1990, Codonics, Inc. is providing a summary of safety and effectiveness information regarding the Codonics NP-1600M and NP-1600MD Medical Color Printer.
General Safety and Effectiveness Concerns:
The device labeling contains instructions for use, indications for use and cautions as applicable.
All hardware components of the Codonics NP-1600M and NP-1600MD have components that have UL, CUL (CSA equivalent), TUV, CE, and FCC certification.
Validation of Effectiveness
Extensive testing of the device has been performed by technical users, by nontechnical users and by potential customers. There is no lossy compression used with this device. Image quality has been verified by radiologists who compared hard copy images printed on the system compared with the original CRT images.
Substantial Equivalence
The Codonics NP-1600M and NP-1600MD Medical Color Printer produces continuous photographic quality hard copies of electronically created or stored images. 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. The intended use and technological characteristics of the system are practically identical to the Kodak XL7720 line of large format continuous tone printers. Any differences between the Codonics, Inc. NP-1600M and NP-1600MD and the equivalent device have no significant influence on safety or effectiveness.
It is our conclusion that there is no hardware device or software component that we know of in the Codonics, Inc., NP-1600M and NP-1600MD whose failure or latent system design flaw would be expected to result in death or injury to a patient