DEPLOYDatabase

Robot model

Ion Endoluminal System

surgicalcommercialby Intuitive Surgical

Intuitive Surgical's Ion Endoluminal System is a robotic-assisted bronchoscopy platform for minimally invasive biopsy of peripheral lung nodules.

Track Ion Endoluminal System
Manufacturer
Intuitive Surgical
Form factor
surgical
Maturity
commercial
Lifecycle
active
Deployments
1

The verified answer

As of Sep 2026, DEPLOY verifies Ion Endoluminal System, a surgical by Intuitive Surgical (commercial): 1 verified deployment on record. 2 sources back the record.

Regulatory status1 FDA 510(k) clearance4 FDA recalls

Ion Endoluminal System holds 1 FDA 510(k) clearance and has 4 FDA recalls on record, per the DEPLOY registry.

See all 5 filings

Overview

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.

Verified vs. claimed

Maturity stage
commercial(Commercially deployed with revenue-generating operations.)
Sources on file
View all sources →

Key facts

FDA clearance

FDA 510(k) cleared in February 2019

Specs

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

Data & sources

Press releases

1

Web sources

1

2 sources backing this record.View all →

Pricing

No verified price is on record for Ion Endoluminal System. Physical-AI systems are often sold through enterprise contracts or operated as a service rather than at a public list price.

How DEPLOY tracks pricing

Deployments (1)

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Ion Endoluminal System on the deployment map

View the global map

Where Ion Endoluminal System is verified operating. Explore the deployment map by place and type.

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Recent activity

Every change to this record is dated, sourced, and independently verified where marked.

  • Record createdJun 5, 2026

    Added to the verified registry

  • Verified media addedVerifiedJun 5, 2026

    Introducing Ion by Intuitive

  • Incident recordedApr 15, 2026

    Intuitive Surgical recalls da Vinci staplers after death and injuries

  • Incident recordedDec 9, 2025

    Intuitive recalls da Vinci S/Si Mega Needle Driver over broken or frayed grip cables

  • Incident recordedJun 18, 2025

    da Vinci SP: patient experienced abdominal pain, bleeding, and wound infection (FDA MAUDE)

Full change history →

Deployment-verified media (1)

PRIMARY SOURCE
Courtesy of Intuitive Surgical

Intuitive Surgical's introduction of Ion, its robotic-assisted bronchoscopy platform for minimally invasive peripheral-lung biopsy. Physician-driven via a shape-sensing catheter; not autonomous.

From deployment: United States

Regulatory filings (5)

Safety record

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

serious
5
recall
3
injury
2

Most recent: Apr 2026

Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.

Incidents affecting Ion Endoluminal System (5)

Includes incidents linked directly to this model or to deployments of it. Retracted incidents are excluded from this view but remain reachable at their canonical URLs.

Sources (2)

  1. https://isrg.intuitive.com/news-releases/news-release-details/u-s-fda-grants-clearance-ion-intuitive/
  2. https://www.sages.org/publications/tavac/intuitive-ion-endoluminal-system/

Common questions

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.
How much does Ion Endoluminal System cost?
Ion Endoluminal System's price is not publicly disclosed. DEPLOY has no verified price on record for Ion Endoluminal System from Intuitive Surgical. Physical-AI systems like this are often sold through enterprise contracts or operated as a service rather than at a public list price; check the manufacturer for the latest.
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 69% 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.
Methodology: Verified · 2 sources (1 primary) · last reviewed 2026-07-14

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-14

Maturity + lifecycle

Maturity stage: commercial

Lifecycle: active

Architectural position

Cohort: surgical

Sources by quality tier

1
primary-company-ir
Company IR disclosure
1
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Ion Endoluminal System.

Recent coverage

Ion Endoluminal System in third-party press

Intuitive Surgical Stock Is Up Over 400%. Here's Why It's Still a No-Brainer Buy. - The Motley Fool

Jun 27, 2026

Intuitive Surgical Stock Is Up Over 400%. Here's Why It's Still a No-Brainer Buy. - Yahoo Finance

Jun 27, 2026

Alva Industries raises EUR 16M for electric motor technology

Jun 26, 2026