# Pie Medical

- Location (FDA's records): Indianpolis, IN
- FDA decisions: 12 (2000–2006): 12 510(k) clearances
- Product codes: IYN (5), IYO (5), LLZ (2)
- Predicates its devices cite: 22 (10 its own); citations of its devices by later devices: 23 (10 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
- Biosound Esaote, Inc.: 3 (https://510kreport.com/company/biosound-esaote)
- Sonometric Health, LLC: 1 (https://510kreport.com/company/sonometric-health)
- Advanced Technology Laboratories, Inc.: 1 (https://510kreport.com/company/advanced-technology-laboratories)
- Hudson Diagnostic Imaging, LLC: 1 (https://510kreport.com/company/hudson-diagnostic-imaging)
- Sonosite,Inc.: 1 (https://510kreport.com/company/sonosite)
- Medison Co., Ltd.: 1 (https://510kreport.com/company/medison)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Touritu Engineering Co., Inc.: 1 (https://510kreport.com/company/touritu-engineering)

## Firms that cite its devices most
- Esaote Europe B.V.: 5 (https://510kreport.com/company/esaote-europe)
- Esaote, S.p.A.: 2 (https://510kreport.com/company/esaote)
- Signostics Pty, Ltd.: 2 (https://510kreport.com/company/signostics)
- Ardent Sound, Inc.: 1 (https://510kreport.com/company/ardent-sound)
- Mobilsonic, Inc.: 1 (https://510kreport.com/company/mobilsonic)
- Atheropoint, LLC: 1 (https://510kreport.com/company/atheropoint)
- Mediwatch, Ltd.: 1 (https://510kreport.com/company/mediwatch)

## Its most-cited devices
- K020112: 50S Tringa Ultrasound Imaging System (2002), cited by 6
- K043360: Imt.Lab (2005), cited by 3
- K043588: Mylab 15 / Mylab 20, Model 2700 (2005), cited by 3
- K002880: 300LC Ultrasound Imaging Systems, Model 300LC (2000), cited by 2
- K053154: MYLAB15/20 3D/4D Ultrasound Imaging System (2005), cited by 2
- K023512: Picus Ultrasound Imaging Systems (2003), cited by 2

## Recent decisions
- K061961: Art Lab Software (Sep 6, 2006)
- K053154: MYLAB15/20 3D/4D Ultrasound Imaging System (Dec 16, 2005)
- K043588: Mylab 15 / Mylab 20, Model 2700 (Jan 25, 2005)
- K043360: Imt.Lab (Jan 5, 2005)
- K041675: Picus, Parus, Falco and Aquila Ultrasound Systems (Jul 23, 2004)
- K033604: Tringa Ultrasound Imaging System, Model 50L (Dec 15, 2003)
- K023512: Picus Ultrasound Imaging Systems (Jan 24, 2003)
- K020112: 50S Tringa Ultrasound Imaging System (Apr 19, 2002)

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