510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Intelerad Medical Systems Incorporated

MONTREAL Quebec, CA

INTELERAD MEDICAL SYSTEMS INCORPORATED appears in FDA device records in MONTREAL Quebec, CA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
5
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Intelerad Medical Systems Incorporated carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Intelerad Medical Systems, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 5 510(k) clearances for Intelerad Medical Systems Incorporated between 2003 and 2020. The busiest year on record is 2003, with 1. The most recent is 2020, with 1.

Clearances by year, as a table
510(k) clearance decisions for Intelerad Medical Systems Incorporated, by decision year
YearClearances
20031
20071
20091
20151
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K192176IntelePACSLLZSubstantially Equivalent
K150707IntelePACSLLZSubstantially Equivalent
K083520INTELEPACS, MODEL VERSION 3.X.XLLZSubstantially Equivalent
K070080INTELEPACSLLZSubstantially Equivalent
K032533INTELEPACSLLZSubstantially Equivalent

Registered establishments

FDA registered establishments for Intelerad Medical Systems Incorporated, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96159163003768392INTELERAD MEDICAL SYSTEMS INCORPORATED800, Boul. de Maisonneuve Est, MONTREAL Quebec H2L 4L8 CA2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0723-2026IntelePACS - InteleConnect / TechPortalSoftware 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 Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.Class IIOpen, Classified
Z-1208-2025IntelePACS (Image Fusion Module) - InteleViewerA 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 DST transition occurs; all other dates are unaffected. An incorrect SUV may lead to an incorrect diagnosis.Class IIOpen, Classified
Z-2267-2014IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.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 partially truncated.Class IITerminated
Z-1885-2009IntelePACS Picture Archiving Communications System InteleViewer module, Model #3.X.X.Product software versions 3.5.2.P1 to 3.5.2.p56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive were defective.Terminated
Z-1884-2009IntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X.Product software versions 3.5.2.P1 to 3.5.2.p56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive were defective.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain