Facility

DIGISONICS, INC.

3 recall(s) on record — most severe on record: Class II.

Key facts

3recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1626313
Establishment type	Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198
Location	305 Church at N Hills St Raleigh, NC, US 27609
Registration status	Active · expires 2026
Parent company	Intelerad Medical Systems Incorporated (owner-operator 9040757)
Brand names	Doctors Review System

Activity by year

Recalls (3)
Inspections (2)

Devices registered here (1)

System, Digital Image Communications, Radiological
Product code LMD (opens in a new tab) · Class I · Radiology · 21 CFR 892.2020

Recalls & enforcement

Class IIOngoing2025-10-17
Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Refe…
Class IIOngoing2025-02-05
A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight Savings Time (DST); only on dates in which…
Class IITerminated2014-07-03
In specific situation a partially truncated file may be written to the IntelePACS server. This partially truncated file still can be viewed by InteleViewer and InteleViewer will report to the user that the file in question is complete. This situation only occurs if a file is pa…

FDA inspections (2)

NAI2024-08-12
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2016-12-30
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “DIGISONICS, INC. (FEI 1626313) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1626313-digisonics-inc/

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