Updated 23 October 2026

Imaging and radiology equipment distributors in the United States: 936 licensed establishments

The United States has 6 independent distributors in the Index so far.

The Bastion Hale Distributor Index lists 936 establishments in the United States whose registry records include imaging, radiology and radiotherapy: 6 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 279 manufacturers' own import or sales entities, 0 regulatory representatives, and 651 manufacturers or exporters, out of 10,187 medical device establishments in the United States overall. The records come from US FDA (openFDA), Health Canada and MHRA UK, last seen on 23 October 2026.

936establishments
6independent distributors
279makers' own sales entities
651manufacturers only

Listed

Independent distributors in the Index here, ranked by the lines each distributor carries, then registrations, then size.

  1. 1
    PROBO MEDICAL, INC.Fishers, IN
    0 lines2 registrationssize 26.1
  2. 2
    United Imaging Healthcare North America, IncHouston, TX
    0 lines1 registrationsize 31.4
  3. 3
    MEDLINK IMAGING, LLC.Pine Brook, NJ
    0 lines1 registrationsize 27.9
  4. 4
    EPICA HUMAN HEALTHLandrum, SC
    0 lines1 registrationsize 21.1
  5. 5
    XTECHDENTAL INCFort Lee, NJ
    0 lines1 registrationsize 18.5
  6. 6
    CARANX, INC.Claymont, DE
    0 lines1 registrationsize 16.5
Include manufacturers, their own sales entities and regulatory representatives (930)

Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.

  1. 1
    Boston Scientific CorporationCoventry, RI
    0 lines520 registrationssize 80.6
  2. 2
    Covidien LLCNorth Haven, CT
    0 lines454 registrationssize 80.4
  3. 3
    ICU Medical, Inc.SOUTHINGTON, CT
    0 lines353 registrationssize 79.3
  4. 4
    Abbott MedicalPLANO, TX
    0 lines299 registrationssize 80.8
  5. 5
    ZIMMER, INC.WARSAW, IN
    0 lines249 registrationssize 80.6
  6. 6
    HOLOGIC, INC.Marlborough, MA
    0 lines245 registrationssize 74.6
  7. 7
    Conmed CorporationWESTBOROUGH, MA
    0 lines222 registrationssize 80.1
  8. 8
    Becton, DIckinson and CompanyCockeysville, MD
    0 lines204 registrationssize 81.4
  9. 9
    COOK, INCORPORATEDELLETTSVILLE, IN
    0 lines202 registrationssize 79.4
  10. 10
    MERIT MEDICAL SYSTEMS, INC.South Jordan, UT
    0 lines199 registrationssize 77.4
  11. 11
    Bausch & Lomb IncorporatedManchester, MO
    0 lines151 registrationssize 77.0
  12. 12
    Smith & Nephew, Inc.,MEMPHIS, TN
    0 lines137 registrationssize 78.8
  13. 13
    Teleflex Medical Inc.Morrisville, NC
    0 lines114 registrationssize 78.6
  14. 14
    ASPEN SURGICAL PRODUCTS, INC.Caledonia, MI
    0 lines113 registrationssize 75.3
  15. 15
    MEDTRONIC SOFAMOR DANEK USA, INC.Memphis, TN
    0 lines109 registrationssize 77.0
  16. 16
    WELCH ALLYN, INC.Skaneateles Falls, NY
    0 lines105 registrationssize 74.0
  17. 17
    Avanos Medical, Inc.Alpharetta, GA
    0 lines104 registrationssize 70.4
  18. 18
    COOPERSURGICAL, INC.Trumbull, CT
    0 lines103 registrationssize 70.5
  19. 19
    Kerr CorporationORANGE, CA
    0 lines92 registrationssize 73.7
  20. 20
    Edwards Lifesciences LLCDraper, UT
    0 lines89 registrationssize 65.3

The Next 10 Markets report does not cover imaging, radiology or radiotherapy devices. The Index and Market Watch stay free.

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Imaging, radiology and radiotherapy covers X-ray, ultrasound, CT, MRI, nuclear medicine and treatment systems. The Index lists these establishments because the registries contain them.

By role

RoleEstablishmentsShareWhat it means
Importer27129%Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence.
Distributor495%Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH).
Registration holder23725%Holds device licences or registrations in its own name (Health Canada MDALL licence holder).
Manufacturer91798%Registered as a manufacturer with an address in this market, including foreign registrations.
Exporter889%Registered with the US FDA as an exporter of devices made for export.

An establishment can hold several roles, so the shares add to more than 100%.

Who holds the registration in the United States

In the United States the manufacturer registers its own establishment with the FDA and lists its devices; there is no local holder requirement. A US importer must also register as an initial importer, and the 510(k) or PMA stays in the manufacturer's name, so a distributor can be replaced without losing market access.

This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later.

Questions about imaging, radiology and radiotherapy distributors in the United States

How many imaging, radiology and radiotherapy distributors are there in the United States?

The Index counts 936 establishments in the United States with imaging, radiology and radiotherapy in their registry record, of which 6 are independent distributors (a channel role and no manufacturing of their own). The number comes from US FDA (openFDA), Health Canada and MHRA UK and was last refreshed on 23 October 2026.

Who can hold an imaging, radiology and radiotherapy device registration in the United States?

In the United States the manufacturer registers its own establishment with the FDA and lists its devices; there is no local holder requirement. A US importer must also register as an initial importer, and the 510(k) or PMA stays in the manufacturer's name, so a distributor can be replaced without losing market access.

How do I find an imaging, radiology and radiotherapy distributor in the United States?

Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and the United States to see the top three names. The Next 10 Markets report does not cover imaging, radiology or radiotherapy devices.

What does the Distributor Index count as an imaging, radiology and radiotherapy distributor in the United States?

A company that appears in a public regulatory registry with an address in the United States and whose linked device listings fall in the imaging, radiology and radiotherapy segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.

Other segments in the United States

General hospital and consumables 2,852Surgery and endoscopy 2,777Patient monitoring and neurology 2,544Gastroenterology, urology and OB/GYN 1,525Orthopaedics, spine and trauma 1,453Dental 1,355In-vitro diagnostics 1,354Cardiovascular 1,303Anaesthesia and respiratory 1,070Ophthalmic 989Ear, nose and throat 906Aesthetics, dermatology and lasers 169

Imaging, radiology and radiotherapy in other North America markets

Canada 118

Sources

Index build 23 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.

Registry data. Bastion Hale does not vouch for any establishment.