LR 5200 LASER FILM RECORDER
Device Facts
| Record ID | K964414 |
|---|---|
| Device Name | LR 5200 LASER FILM RECORDER |
| Applicant | Bayer Corp., Agfa Div. |
| Product Code | LMC · Radiology |
| Decision Date | Jan 27, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2040 |
| Device Class | Class 2 |
Indications for Use
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.
Device Story
LR 5200 laser film recorder; uses Helium-neon laser to produce gray-scale diagnostic images on photo-sensitive film. Interfaces with host imaging devices (MRI, CT, Ultrasound, Mammography, Digital Radiography, Nuclear Medicine). Operates by modulating light source with patient image data; writes image to film for physician review. Used in clinical radiology settings; assists physicians in diagnosing conditions typical to radiological examinations.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Helium-neon laser light source; modulated light output; photo-sensitive film medium; standalone film recorder unit; interfaces with external host imaging modalities.
Indications for Use
Indicated for producing high-quality gray-scale diagnostic medical images from host imaging modalities including MRI, CT, Ultrasound, Mammography, Digital Radiography, and Nuclear Medicine for use in radiological examinations.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- AGFA LR 3300
- AGFA COMPACT L
- DUPONT LP 400
- FUJI FL-IMD
- POLAROID HELIOS 1417
Related Devices
- K012010 — MODIFICATION TO LR 5200 FILM RECORDER · Agfa Corp. · Sep 20, 2001
- K042133 — DRY LASER IMAGER, MODEL DRYPRO MODEL 793 · Konica Minolta Medical & Graphic, Inc. · Nov 24, 2004
- K083522 — SONY UP-DF750 DIGITAL FILM IMAGER · Sony Electronics, Inc. · Jan 9, 2009
- K081637 — LASER IMAGER DRYPRO MODEL 873 · Konica Minolta Medical & Graphic, Inc. · Jul 1, 2008
- K992586 — KONICA LASER IMAGER, DRYPRO MODEL 722 · Konica Corp. · Oct 29, 1999
