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Stentor, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
3
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Stentor, Inc. makes

Stentor, Inc. makes the Stentor Pageview, ISITE PACS, and ISITE Radiology devices.

These devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

  • Stentor, Pageview Ref K992698

    Class I
    Active 510(k) 510(k) I

  • Isite Pacs Ref K042292

    Class II
    Active 510(k) 510(k) II

  • Isite Radiology Ref K013630

    Class II
    Active 510(k) 510(k) II

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Stentor, Inc., initiated on 2005-12-20. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2005

    • 20 Dec 2005 Z-0399-06 Unclassified (pre-2012) Terminated When using a third party dictation accessory with the iSite PACS, a malfunction may occur that would result in the petient/exam selected and shown may be different on the radiologist console and diagnostic display screens Distribution: Product was distributed nationwide to 66 direct consignees. There were no shipments to U.S. Government facilities or…
      Full distribution text Product was distributed nationwide to 66 direct consignees. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
      Submission number: K042292

Frequently asked questions

How many devices does Stentor, Inc. have in the registry?

The registry currently lists 3 devices for Stentor, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Stentor, Inc.'s devices?

Among its 3 most recently registered devices, Stentor, Inc. has devices listed in FDA 510(k) (3 devices).

What risk classes do Stentor, Inc.'s devices fall under?

Among its 3 most recently registered devices, the classes recorded for Stentor, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Stentor, Inc.?

FDA recall records list 1 recall initiated by Stentor, Inc., the most recent initiated on 2005-12-20. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Stentor, Inc. in the registry?

The most recently registered devices listed for Stentor, Inc. include STENTOR, PAGEVIEW, ISITE PACS and ISITE RADIOLOGY.

Generated automatically from registry data and not verified by a human reviewer.