Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.2030](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.2030) → LMA — Digitizer, Image, Radiological # LMA · Digitizer, Image, Radiological _Radiology · 21 CFR 892.2030 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA ## Overview - **Product Code:** LMA - **Device Name:** Digitizer, Image, Radiological - **Regulation:** [21 CFR 892.2030](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.2030) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) ## Identification A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices. ## Classification Rationale Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). 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. ## Special Controls *Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). 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. ## Recent Cleared Devices (20 of 61) Showing 20 most recent of 61 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K132183](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K132183.md) | DICOM VIDEO | Bar Code Computer, Ltd. | Oct 3, 2013 | SESE | | [K130636](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K130636.md) | TELERADPRO EDGE; TELERADPRO EDGE HD-CCD | Vidar Systems Corp. | Jun 7, 2013 | SESE | | [K130406](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K130406.md) | DIAGNOSTICPRO EDGE | Vidar Systems Corp. | Apr 29, 2013 | SESE | | [K102476](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K102476.md) | TELERADPRO | Vidar Systems Corp. | Oct 7, 2010 | SESE | | [K093809](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K093809.md) | VIDAR DENTAL FILM DIGITIZER | Vidar Systems Corp. | Jan 7, 2010 | SESE | | [K091288](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K091288.md) | MEDI-6000 MEDICAL IMAGE DIGITIZER | Microtek International, Inc. | Aug 14, 2009 | SESE | | [K063424](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K063424.md) | FILM DIGITZER, MODEL 2908 MAMMO PRO | Array Corp. | Dec 21, 2006 | SESE | | [K042484](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K042484.md) | NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER | Nai Technology Products | Oct 20, 2004 | SESE | | [K033637](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K033637.md) | MEDICAL IMAGE DIGITIZER, MODEL 2908 | Array Corp. | Dec 17, 2003 | SESE | | [K032022](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K032022.md) | DIGITAL IMAGER | Pyramid Medical, Inc. | Sep 2, 2003 | SESE | | [K022810](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K022810.md) | COBRASCAN CR-1 FILMLESS | Radiographic Digital Imaging, Inc. | Oct 11, 2002 | SESE | | [K021949](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K021949.md) | FULCRUM | Howtek, Inc. | Aug 12, 2002 | SESE | | [K020243](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K020243.md) | LASERPRO 16 | Eradlink, Inc. | Mar 5, 2002 | SESE | | [K013631](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K013631.md) | EFILM VIDEO | Efilm Medical, Inc. | Nov 20, 2001 | SESE | | [K013395](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K013395.md) | LIFEJET VIDEO LINK | Ferrania S.P.A. | Oct 30, 2001 | SESE | | [K011049](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K011049.md) | EXPRESSSUITE | Vidar Systems Corp. | Oct 1, 2001 | SESE | | [K001841](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K001841.md) | 35/CD CINECONVERTER | Tagarno A/S | Nov 15, 2000 | SESE | | [K000411](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K000411.md) | CHILI VIDEO, CHILI VIDEOPRO | Steinbeis-Transferzentrum Medizinische Informatik | Apr 14, 2000 | SESE | | [K992467](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K992467.md) | IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM | Dba Systems, Inc. | Feb 10, 2000 | SESE | | [K993598](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA/K993598.md) | MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 | Vidar Systems Corp. | Jan 20, 2000 | SESE | ## Top Applicants - Vidar Systems Corp. — 10 clearances - Lumisys, Inc. — 5 clearances - Array Corp. — 3 clearances - Eastman Kodak Company — 3 clearances - Howtek, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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