# LMD: System, Digital Image Communications, Radiological

- Device class: 1; regulation: 21 CFR 892.2020; FDA's rule: 510(k) exempt
- FDA decisions: 142
- Recalls: 10 (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)
- 1991: 3
- 1992: 9
- 1993: 22
- 1994: 14
- 1995: 21
- 1996: 20
- 1997: 20
- 1998: 14
- 1999: 5
- 2000: 1

## Most-cited predicates
- K961023: Aidp (Accuimage Image Display Processor) (1996), cited by 10
- K962699: Radworks Medical Imaging Software (1996), cited by 9
- K970064: Amicas Web/Intranet Image Server (1997), cited by 8
- K973959: Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software (1997), cited by 6
- K971347: Medisurf (1997), cited by 5
- K953398: Uniscan (1995), cited by 5
- K972701: Barco MWD 321 Medical Workstation Display (1998), cited by 4
- K960911: Netra Workstation System & Netra MD Software (1996), cited by 4
- K922164: Raytel Digital Imaging Systems (1993), cited by 4
- K931551: Kodak Ektascan Imagelink System (Keis) (1993), cited by 3

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