(87 days)
Camtronics Ltd. MultiCam System 2200
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No
The description focuses on image retrieval and printing, explicitly stating no image processing or compression is used, and there are no mentions of AI or ML terms.
No
The device is described as a multi-format camera used for retrieving and copying medical images, and passing them to film recorders. It does not directly treat or diagnose a medical condition.
No
The device retrieves and copies medical images, and passes them to film recorders. It does not perform any analysis, interpretation, or diagnosis based on these images. Its function is to produce physical outputs of existing images for review, not to derive diagnostic information itself.
No
The device description explicitly states it is a "multi format camera" and performs physical actions like making film copies, indicating it is a hardware device with software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to retrieve medical images from storage and create film copies or pass them to other film recorders. This is related to image display and output, not to analyzing biological samples or providing diagnostic information based on in vitro testing.
- Device Description: The description confirms its function as a multi-format camera for image retrieval and film output.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on such analysis. The device deals with pre-existing medical images.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device's function falls outside of that scope.
N/A
Intended Use / Indications for Use
The Aspect Electronics, Inc. Opticam is a multi format camera used for retrieving medical images stored on magneto optical disk (removable media) and makes monochrome 8" x 10" film copies in a six on one format. It also passes color images to color film recorders via a SCSI bus.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Aspect Electronics, Inc. Opticam is a multi format camera used for retrieving medical images stored on magneto optical disk (removable media) and makes monochrome 8" x 10" film copies in a six on one format. It also passes color images to color film recorders via a SCSI bus. The hardware components of the Aspect Opticam are mainly off-the-shelf computer components that have IEC 601 certification. The unit itself currently has the CSA Mark. The computer equipment complies with part 18 of the FCC rules.
Mentions image processing
There is no image processing or compression used with this device.
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 programmers, by nonprogrammers and by potential customers. Image quality of the device has been validated by radiologists who compared hard copy images with the original CRT.
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.
Camtronics Ltd. MultiCam System 2200
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.
0
SUMMARY STATEMENT OF SAFETY and EFFECTIVENESS
AUG 2 3 1996
In accordance with the provisions of the Safe Medical Device Act of 1990, Aspect Electronics, Inc. is providing a summary of safety and effectiveness information regarding the Aspect Opticam Film Recorder, Multi Format Camera.
General Safety and Effectiveness Concerns:
The device labeling contains instructions for use, indications for use and cautions.
The hardware components of the Aspect Opticam are mainly off-the-shelf computer components that have IEC 601 certification. The unit itself currently has the CSA Mark. The computer equipment complies with part 18 of the FCC rules.
Validation of Effectiveness
Extensive testing of the device has been performed by programmers, by nonprogrammers and by potential customers. Software used in the device is only used for control purposes and has no bearing on image quality. There is no image processing or compression used with this device. Image quality of the device has been validated by radiologists who compared hard copy images with the original CRT.
Substantial Equivalence
The Aspect Electronics, Inc. Opticam is a multi format camera used for retrieving medical images stored on magneto optical disk (removable media) and makes monochrome 8" x 10" film copies in a six on one format. It also passes color images to color film recorders via a SCSI bus. The intended use and technological characteristics of the system are similar to the Camtronics Ltd. MultiCam System 2200. Any differences between the Aspect Opticam System 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 Aspect Opticam System whose failure or latent system design flaw would be expected to result in death or injury to a patient.