Ion Endoluminal System

[commercial]

surgical · food-service · 1 deployments in catalog

Manufacturer

Intuitive Surgical

Form Factor

surgical

Lifecycle

commercial

Operational Reality

Audited

Deployments

1

Target Price

Custom Quote

  • SURGICAL
  • COMMERCIAL

Description

Intuitive Surgical's Ion Endoluminal System is a robotic-assisted bronchoscopy platform for minimally invasive biopsy of peripheral lung nodules. It uses an ultra-thin, shape-sensing maneuverable catheter with PlanPoint CT-based airway planning to reach lesions deep in the peripheral lung. FDA 510(k) cleared in February 2019 and commercially deployed across US hospitals, with subsequent AI and advanced-imaging integration clearances.

Key facts & specs

12 entries
website
https://isrg.intuitive.com/news-releases/news-release-details/u-s-fda-grants-clearance-ion-intuitive/
maturity
commercial
lifecycle
active
form factor
surgical
manufacturer
Intuitive Surgical
deployments count
1
Maturity stage
commercial
Pathway
FDA 510(k) cleared 2019-02-20 (clearance number not corroborated to bar)
Modality
shape-sensing robotic-assisted bronchoscopy
Planning
PlanPoint CT-based airway planning
Indication
peripheral lung nodule biopsy
F D A clearance
FDA 510(k) cleared in February 2019

Safety record

Safety Status
2 incident(s) logged

3 recalls and 2 incidents on record (5 serious). Most recent: Apr 2026.

Risk Metrics
Incidents: 2
Recalls: 3
Latest: Apr 2026
serious: 5

FAQ

11 entries
What is Ion Endoluminal System?

Intuitive Surgical's Ion Endoluminal System is a robotic-assisted bronchoscopy platform for minimally invasive biopsy of peripheral lung nodules. It uses an ultra-thin, shape-sensing maneuverable catheter with PlanPoint CT-based airway planning to reach lesions deep in the peripheral lung. FDA 510(k) cleared in February 2019 and commercially deployed across US hospitals, with subsequent AI and advanced-imaging integration clearances.

Is Ion Endoluminal System actually deployed in the real world?

Yes. Ion Endoluminal System is independently verified in real-world operation on the DEPLOY registry, confirmed at named deployment sites with primary sources: not a concept, render, or demo-only.

Who makes Ion Endoluminal System?

Ion Endoluminal System is made by Intuitive Surgical, based in Sunnyvale, California, USA, founded in 1995.

Where is Ion Endoluminal System deployed?

1 verified deployment of Ion Endoluminal System is on the DEPLOY registry, including at United States.

Can you buy Ion Endoluminal System?

Ion Endoluminal System is in commercial deployment and is sold to operators; contact the manufacturer to buy, and see the pricing section for any recorded price.

Is Ion Endoluminal System FDA cleared?

Ion Endoluminal System has 5 regulatory records on the DEPLOY registry: FDA recall (Z-1134-2026), recalled; FDA recall (Z-2720-2024), recalled; FDA recall (Z-0106-2022), recalled and 2 more. See the Regulatory filings section for each agency source.

What are alternatives to Ion Endoluminal System?

On the DEPLOY registry, comparable surgical robots to Ion Endoluminal System include da Vinci (and Ion), Edge Multi-Port Surgical Robot, Edison Histotripsy System, Stryker Mako SmartRobotics.

How does Ion Endoluminal System compare to da Vinci (and Ion)?

Ion Endoluminal System and da Vinci (and Ion) (Intuitive Surgical · 15 deployments) are both surgical robots on the DEPLOY registry. Ion Endoluminal System has 1 verified deployment on record. Compare both records for specs, safety, deployments, and verified-vs-claimed autonomy.

Is Ion Endoluminal System a top surgical?

On DEPLOY's intelligence score, which blends verified deployments, safety, adoption, media, and IP signals, Ion Endoluminal System ranks in roughly the top 82% of surgical models tracked by the registry.

What is Ion Endoluminal System's maturity stage?

Ion Endoluminal System is at the commercial stage on the DEPLOY maturity ladder (research, prototype, pilot, commercial, production). Commercial stage means production-grade deployments are operating at named customer sites.

Is Ion Endoluminal System safe?

Ion Endoluminal System has 5 active incidents on record in the DEPLOY registry. 3 recalls and 2 incidents on record (5 serious). Most recent: Apr 2026. Retracted incidents are excluded from this count.

Deployments

1 entry

Sectors & applications

1 entry