(83 days)
The diseases and conditions that the device will aid in the diagnosis of, are those that are typical to radiological types of examinations.
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.
There is insufficient information in the provided text to describe acceptance criteria and associated study details. The document is a 510(k) summary for a "Laser Film Recorder" and focuses on device description, technological characteristics, and substantial equivalence to other devices. It does not contain any details about acceptance criteria for performance metrics, clinical studies, or AI/algorithm performance.
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JAN 24 1997
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510(k) Summary
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| DATE SUMMARY PREPARED | November 19, 1996 |
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| SUBMITTER | Bayer Corporation, AGFA Division100 Challenger RoadRidgefield Park, New Jersey 07660Contact Person: Michael SullivanPhone: (201) 440-0111 x4610Fax: (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 3300AGFA COMPACT LDUPONT LP 400FUJI FL-IMDPOLAROID HELIOS 1417 |
| DEVICE DESCRIPTION | The LR 5200 is a laser based (Helium-neon) filmrecorder, designed for producing high qualitygray scale diagnostic medical images, wheninterfaced to a host imaging device. Typicalhost imaging devices would include those ofMagnetic Resonance, Computed Tomography,Ultrasound, Mammography, DigitalRadiography, and Nuclear Medicine imagingmodalities. The diseases and conditions that thedevice will aid in the diagnosis of, are those thatare typical to radiological types of examinations. |
| TECHNOLOGICAL CHARACTERISTICS. | The LR 5200 has the same technologicalconsiderations as those mentioned above in theSubstantially Equivalent Device section. Theseare a light source that becomes modulated withthe patient image information and then writtenon a photo sensitive medium for viewing by thediagnosing physician. |
N/A