# LMC: Camera, Multi Format, Radiological

- Device class: 2; regulation: 21 CFR 892.2040; FDA's rule: 510(k) exempt
- FDA decisions: 121
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2002: 4
- 2003: 4
- 2004: 6
- 2005: 1
- 2006: 3
- 2007: 1
- 2008: 1
- 2009: 3
- 2011: 1
- 2014: 2

## Most-cited predicates
- K021054: Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical Multimedia Grey Scale Dry Imager (2002), cited by 4
- K002146: Kodak Dryview 8610 Laser Imager / for Mammography (2000), cited by 3
- K010275: Drystar 4500 Printer, Model 4500 (2001), cited by 3
- K023287: Drystar 5500 (2002), cited by 3
- K964414: LR 5200 Laser Film Recorder (1997), cited by 3
- K033821: Kodak Dryview 8900 Laser Imager Mammography Accessory (2004), cited by 3
- K012941: Drystar, Model 4500M (2001), cited by 3
- K042133: Dry Laser Imager, Model  Drypro Model 793 (2004), cited by 2
- K003481: Codonics NP-1660 Series Medical Printers, Model 1660 (2001), cited by 2
- K912073: Polaroid Helios Laser Imager (1991), cited by 2

Source page: https://510kreport.com/product-code/LMC
Data by year (CSV): https://510kreport.com/product-code/LMC.csv