Dicom Grid, Inc.

Country not established

Devices: 1
FDA recalls: 21 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

What Dicom Grid, Inc. makes

Dicom Grid, Inc. manufactures the DG PACS, which is a Class II medical device.

The company is based in the US and its products are listed in the FDA 510(k) registry.

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

Catalogue1

Newest first, rows 1-1 of 1

Dg Pacs Ref K152977

Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls2

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

FDA recall records list 2 recalls initiated by Dicom Grid, Inc., the earliest on 2016-12-16 and the most recent on 2025-11-18. By recorded status: 1 ongoing and 1 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware and performance or accuracy. 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.

Recalls initiated per year

2017 0
2018 0
2019 0
2020 0
2021 0
2022 0
2023 0
2024 0
2025 1
2026 0

1 initiated before 2017

2025
- 18 Nov 2025 Z-0941-2026 Class II Ongoing Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up. Distribution: US: AZ, TX, GA, NV, MO, MI, IL, OH, CT, OR, FL, NY, NM, MN, PA, AK, ND, NJ, VA, WA, NC, TN, WI, GA, AK, CA, SD, CO, MA,…
  Full distribution text
  US: AZ, TX, GA, NV, MO, MI, IL, OH, CT, OR, FL, NY, NM, MN, PA, AK, ND, NJ, VA, WA, NC, TN, WI, GA, AK, CA, SD, CO, MA, WV, MN, KS, MD, VT, IA, RI, AL, ID, LA, PR, NH, IN, OK, UT, NE, SC, AR, DE OUS: CA, NZ, AU, GB, BE, FR, IT, NO, SE
  Submission number: K231360
2016
- 16 Dec 2016 Z-1045-2017 Class II Terminated A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance. Distribution: U.S. distribution to the following; TX, FL, NE, CA, WI, AZ, NH, MO, MA, CO, PA, NV, PR, IL, OH, NY, MD, NJ, MN, MI, CT,…
  Full distribution text
  U.S. distribution to the following; TX, FL, NE, CA, WI, AZ, NH, MO, MA, CO, PA, NV, PR, IL, OH, NY, MD, NJ, MN, MI, CT, VA, GA, UT, KS, WA, MI, HI. Foreign distribution to the following; Canada, Spain, Israel, Singapore, Kosovo, Austria, Brazil, Malaysia, Australia.
  Submission number: K152977

Frequently asked questions

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

The registry currently lists 1 device for Dicom Grid, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Dicom Grid, Inc.'s devices?

Among its 1 most recently registered device, Dicom Grid, Inc. has devices listed in FDA 510(k) (1 device).

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

Among its 1 most recently registered device, the classes recorded for Dicom Grid, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Dicom Grid, Inc.?

FDA recall records list 2 recalls initiated by Dicom Grid, Inc., the most recent initiated on 2025-11-18. 1 of them is recorded as ongoing. 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 Dicom Grid, Inc. in the registry?

The most recently registered devices listed for Dicom Grid, Inc. include DG PACS.

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