# Quantib B.V.

- Location (FDA's records): Rotterdam, NL
- FDA decisions: 11 (2016–2026): 11 510(k) clearances
- Product codes: LLZ (9), QIH (1), QDQ (1)
- 510(k) review time since 2016: median 73 days, against 115 for FDA's reviews in the same codes and years (9 of 11 faster)
- Predicates its devices cite: 12 (7 its own); citations of its devices by later devices: 8 (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
- Invivo Corporation: 1 (https://510kreport.com/company/invivo)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Philips Medical Systems Nederlands B.V.: 1 (https://510kreport.com/company/philips-medical-systems-nederlands)
- Medis Medical Imaging Systems BV: 1 (https://510kreport.com/company/medis-medical-imaging-systems)
- Scanmed, LLC: 1 (https://510kreport.com/company/scanmed)

## Firms that cite its devices most
- JLK, Inc.: 1 (https://510kreport.com/company/jlk)

## Its most-cited devices
- K202501: Quantib Prostate (2020), cited by 2
- K213737: Quantib ND (2022), cited by 1
- K173939: Quantib Brain (2018), cited by 1
- K163013: Quantib Brain 1.2 (2017), cited by 1
- K221106: Quantib Prostate (2022), cited by 1
- K153351: Quantib Brain 1 (2016), cited by 1

## Recent decisions
- K253682: DeepHealth ProstateAI (Apr 29, 2026)
- K251527: Brain WMH (Sep 25, 2025)
- K230772: Quantib Prostate (Apr 17, 2023)
- K221106: Quantib Prostate (May 13, 2022)
- K213737: Quantib ND (Jan 14, 2022)
- K202501: Quantib Prostate (Oct 11, 2020)
- K200899: Quantib AI Node (Jun 15, 2020)
- K182564: Quantib ND (Dec 27, 2018)

Source page: https://510kreport.com/company/quantib