# LMB: Device, Digital Image Storage, Radiological

- Device class: 1; regulation: 21 CFR 892.2010; FDA's rule: 510(k) exempt
- FDA decisions: 55
- Recalls: 13 (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)
- 1990: 3
- 1991: 2
- 1992: 3
- 1993: 1
- 1994: 5
- 1995: 7
- 1996: 10
- 1997: 8
- 1998: 2
- 1999: 2

## Most-cited predicates
- K955237: Tigerscan/Tigerview (1996), cited by 6
- K950279: TOMTECP90 (1995), cited by 4
- K964274: Writestar, and Viewstar (1997), cited by 2
- K964803: Univision Echocardiology System (1997), cited by 2
- K960981: Kodak Digital Science (KDS) Medical Image and Information Library (1996), cited by 2
- K901956: Digital 8 W/Other Numerical Suffixes (1-9, Etc.) (1990), cited by 2
- K961160: Upacs Version 1.7 (1996), cited by 2
- K960326: FCR DMS Optical Disk Image Filing Unit OD-F614, ODF614L & Multimodality System (1996), cited by 2
- K963395: Imageserver 2000 Picture Archiving System (1996), cited by 2
- K915094: Vortech's Image Archival and Retrieval System (1991), cited by 1

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