The EU counted 1,791 enterprises in the related industry class.
What this market covers
Integrated suites that combine live imaging with navigation so clinicians can guide catheters, needles and instruments. Hospitals buy them for cardiac, vascular, neuro and oncology procedures.
Typical segments
- Hybrid operating rooms
- Interventional X-ray systems
- Surgical navigation
- Interventional MRI
Why this market is moving now
- US employment in the core industry fell 1% since 2020.
Key figures
Each figure names the source it came from. Open the source list below to read the quoted line.
| Figure | Value | Year | Source |
|---|---|---|---|
| The EU had 1,791 enterprises in NACE class C2660 (Manufacture of irradiation, electromedical and electrotherapeutic equipment) in 2023. | 1,791 enterprises | 2023 | Eurostat |
| EU enterprises in NACE class C2660 had net turnover of €30.54 billion in 2023. | 30.54 EUR billion | 2023 | Eurostat |
| NACE class C2660 employed 74,126 people across the EU in 2021. | 74,126 persons employed | 2021 | Eurostat |
| The US had 2,220 private establishments in NAICS 334510 (Electromedical and electrotherapeutic apparatus manufacturing) in 2025. | 2,220 establishments | 2025 | U.S. Bureau of Labor Statistics |
| NAICS 334510 employed an average of 72,575 people in US private industry in 2025. | 72,575 jobs | 2025 | U.S. Bureau of Labor Statistics |
| US employment in NAICS 334510 changed by -1% between 2020 (73,147 jobs) and 2025, calculated from BLS figures. | -1 % since 2020 | 2025 | U.S. Bureau of Labor Statistics |
| Average annual pay in US NAICS 334510 was $140,429 in 2025. | 140,429 USD per year | 2025 | U.S. Bureau of Labor Statistics |
| The FDA has recorded 4 510(k) clearances for devices named "image guided surgery system". | 4 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Brainlab Ag holds 3 510(k) clearances for devices named "image guided surgery system". | 3 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Schaerer Mayfield Usa, Inc. holds 1 510(k) clearances for devices named "image guided surgery system". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| PubMed indexed 49 papers mentioning "image-guided therapy" in the title or abstract in 2025. | 49 papers | 2025 | U.S. National Library of Medicine |
Sources and method
The figures on this page come from the public sources listed below. Read how we work.
- Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
Quoted lines
- Figure 1
sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs ENT_NR, 2023, 1791
- Figure 2
sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs NETTUR_MEUR, 2023, 30540
- Figure 3
sbs_ovw_act, geo EU27_2020, nace_r2 C2660, indic_sbs EMP_NR, 2021, 74126
- Figure 1
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 334510, 2025 (2026-11-04)
Quoted lines
- Figure 4
QCEW 2025 annual, US000, private, NAICS 334510, annual_avg_estabs 2220
- Figure 5
QCEW 2025 annual, US000, private, NAICS 334510, annual_avg_emplvl 72575
- Figure 6
QCEW 2020 annual_avg_emplvl 73147; 2025 annual_avg_emplvl 72575
- Figure 7
QCEW 2025 annual, US000, private, NAICS 334510, avg_annual_pay 140429
- Figure 4
- U.S. Food and Drug Administration: openFDA 510(k) clearances, device_name "image guided surgery system" (2026-11-04)
Quoted lines
- Figure 8
openFDA device/510k device_name:"image guided surgery system", sum of counts by decision_date = 4
- Figure 8
- U.S. Food and Drug Administration: openFDA 510(k) clearances by applicant, device_name "image guided surgery system" (2026-11-04)
Quoted lines
- Figure 9
applicant.exact "Brainlab AG" count 3
- Figure 10
applicant.exact "Schaerer Mayfield USA, Inc." count 1
- Figure 9
- U.S. National Library of Medicine: PubMed search "image-guided therapy"[tiab] AND 2025[dp] (2026-11-04)
Quoted lines
- Figure 11
esearch count 49
- Figure 11
Buyers and suppliers
Who buys
- Hospitals
- Cardiac and vascular centers
- Ambulatory surgery centers
Companies to watch
Brainlab Ag
3 FDA 510(k) clearances for devices named "image guided surgery system".
Schaerer Mayfield Usa, Inc.
1 FDA 510(k) clearances for devices named "image guided surgery system".
What the full report covers
- 01Executive summary
The answer in one page: size, direction and what moves it - 02Market definition and scope
What is in and out of the United States market - 03Market size, 2021 to 2025
Historical series and growth rates - 04Outlook to 2031
Base, low and high scenarios with stated assumptions - 05Rules, policy and deadlines
Regulation and programmes that change demand - 06Drivers and barriers
What accelerates or slows adoption, by customer segment - 07Prices, costs and margins
Unit economics where public data allows - 08Competitive landscape
8 to 12 company profiles with recent moves - 09Opportunities and risks
For new entrants, suppliers and investors - 10Method and sources
Every assumption and source, listed
Included with the full report
- PDF report, 40 to 60 pages
- Excel data pack
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- Method note and assumptions
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Frequently asked questions
How many image guided therapy system devices are cleared by the FDA?
openFDA lists 4 510(k) clearances for devices named image guided surgery system.
Which companies hold the most FDA clearances for image guided therapy system?
By 510(k) count: Brainlab Ag, Schaerer Mayfield Usa, Inc..
How many US companies are in the image guided therapy system industry?
BLS counts 2,220 private establishments in NAICS 334510 (Electromedical and electrotherapeutic apparatus manufacturing), the closest official industry.
How many EU companies are in the image guided therapy system industry?
Eurostat counts 1,791 enterprises in NACE class C2660 (Manufacture of irradiation, electromedical and electrotherapeutic equipment).
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