# Smart Medical Systems, Ltd.

- Location (FDA's records): Raanana, IL
- FDA decisions: 9 (2006–2022): 9 510(k) clearances
- Product codes: FDF (5), ODC (3), FDA (1)
- 510(k) review time since 2016: median 82 days, against 250 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 10 (7 its own); citations of its devices by later devices: 9 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fujinon, Inc.: 2 (https://510kreport.com/company/fujinon)
- Pentax of America, Inc.: 1 (https://510kreport.com/company/pentax-of-america)

## Firms that cite its devices most
- Crospon, Ltd.: 1 (https://510kreport.com/company/crospon)
- Endostart S.R.L.: 1 (https://510kreport.com/company/endostart)

## Its most-cited devices
- K110291: Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B Device (2011), cited by 2
- K101191: Naviaid Icvi Device (2010), cited by 2
- K060923: Naviaid Bge Device, Model 21-001 (2006), cited by 1
- K111760: Naviaid (TM) BGC Device (2011), cited by 1
- K202469: G-EYE System (2020), cited by 1
- K102616: Naviaid Balloon Guided Colonoscopy (BGC) Device (2010), cited by 1

## Recent decisions
- K220158: G-EYE System (Apr 11, 2022)
- K202469: G-EYE System (Oct 26, 2020)
- K192588: G-EYE System (Apr 15, 2020)
- K112106: Naviaid Icvi-F,S,B,R Device (Feb 6, 2012)
- K111760: Naviaid (TM) BGC Device (Aug 9, 2011)
- K110291: Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B Device (Jun 17, 2011)
- K102616: Naviaid Balloon Guided Colonoscopy (BGC) Device (Dec 30, 2010)
- K101191: Naviaid Icvi Device (Jul 27, 2010)

Source page: https://510kreport.com/company/smart-medical-systems