(83 days)
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No
The device description focuses on laser-based film recording technology and does not mention any AI or ML components or functionalities.
No
The device is a film recorder used to produce diagnostic medical images from various imaging modalities, aiding in diagnosis rather than providing therapy.
Yes
The device aids in the diagnosis of diseases and conditions by producing high-quality grayscale diagnostic medical images from host imaging devices, acting as a component in the diagnostic workflow for a "diagnosing physician."
No
The device description explicitly states it is a "laser based (Helium-neon) film recorder," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The LR 5200 is a film recorder that produces images from various medical imaging modalities (MRI, CT, Ultrasound, etc.). It processes and outputs images generated by other diagnostic devices, but it does not directly analyze biological samples.
- Intended Use: The intended use is to aid in the diagnosis of diseases and conditions typical to radiological examinations, which are image-based, not sample-based.
- Lack of Biological Sample Analysis: There is no mention of the device interacting with or analyzing any biological samples.
Therefore, the LR 5200 falls under the category of a medical imaging device accessory or output device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The LR 5200 is a laser based (Helium-neon) film recorder, designed for producing high quality gray scale diagnostic medical images, when interfaced to a host imaging device. Typical host imaging devices would include those of Magnetic Resonance, Computed Tomography, Ultrasound, Mammography, Digital Radiography, and Nuclear Medicine imaging modalities. The diseases and conditions that the device will aid in the diagnosis of, are those that are typical to radiological types of examinations.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance, Computed Tomography, Ultrasound, Mammography, Digital Radiography, and Nuclear Medicine imaging modalities
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
diagnosing physician
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)
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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.
0
JAN 24 1997
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510(k) Summary
..............................................................................................................................................................................
| DATE SUMMARY PREPARED | November 19, 1996 |
|---|---|
| SUBMITTER | Bayer Corporation, AGFA Division |
| 100 Challenger Road | |
| Ridgefield Park, New Jersey 07660 | |
| Contact Person: Michael Sullivan | |
| Phone: (201) 440-0111 x4610 | |
| Fax: (201) 440-4376 | |
| DEVICE COMMON OR USUAL NAME | Laser Film Recorder |
| DEVICE PROPRIETARY NAME | LR 5200 Laser Film Recorder |
| SUBSTANTIAL EQUIVALENCE DEVICES | |
| (CLASS II DEVICE) | AGFA LR 3300 |
| AGFA COMPACT L | |
| DUPONT LP 400 | |
| FUJI FL-IMD | |
| POLAROID HELIOS 1417 | |
| DEVICE DESCRIPTION | The LR 5200 is a laser based (Helium-neon) film |
| recorder, designed for producing high quality | |
| gray scale diagnostic medical images, when | |
| interfaced to a host imaging device. Typical | |
| host imaging devices would include those of | |
| Magnetic Resonance, Computed Tomography, | |
| Ultrasound, Mammography, Digital | |
| Radiography, and Nuclear Medicine imaging | |
| modalities. The diseases and conditions that the | |
| device will aid in the diagnosis of, are those that | |
| are typical to radiological types of examinations. | |
| TECHNOLOGICAL CHARACTERISTICS. | The LR 5200 has the same technological |
| considerations as those mentioned above in the | |
| Substantially Equivalent Device section. These | |
| are a light source that becomes modulated with | |
| the patient image information and then written | |
| on a photo sensitive medium for viewing by the | |
| diagnosing physician. |