← Product Code [LMC](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMC) · K964414 # LR 5200 LASER FILM RECORDER (K964414) _Bayer Corp., Agfa Div. · LMC · Jan 27, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMC/K964414 ## Device Facts - **Applicant:** Bayer Corp., Agfa Div. - **Product Code:** [LMC](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMC.md) - **Decision Date:** Jan 27, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2040 - **Device Class:** Class 2 - **Review Panel:** Radiology ## 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. ## Regulatory 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 ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} JAN 24 1997 K964414 # 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. AGFA LR 3300 (CLASS II DEVICE) 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. --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMC/K964414](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMC/K964414) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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