# Bracco Diagnostic, Inc.

- Location (FDA's records): Monroe Township, NJ
- FDA decisions: 3 (2011–2014): 3 510(k) clearances
- Product codes: FCX (3)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- E-Z-Em, Inc.: 4 (https://510kreport.com/company/e-z-em)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)
- Olympus America, Inc.: 1 (https://510kreport.com/company/olympus-america)

## Firms that cite its devices most
- Baronova, Inc.: 1 (https://510kreport.com/company/baronova)
- Ide Vision, Ltd.: 1 (https://510kreport.com/company/ide-vision)
- Nexcore Technology, LLC: 1 (https://510kreport.com/company/nexcore-technology)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)

## Its most-cited devices
- K111648: Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator (2011), cited by 3
- K132192: Bracco Diagnostics Inc. Protoco, L Touch Colon Insufflator (2014), cited by 1

## Recent decisions
- K132192: Bracco Diagnostics Inc. Protoco, L Touch Colon Insufflator (Feb 14, 2014)
- K123047: Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing Set (Aug 6, 2013)
- K111648: Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator (Nov 3, 2011)

Source page: https://510kreport.com/company/bracco-diagnostic