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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radiology-diagnostic kit
Definition FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOIP
Regulation Number 892.1680
Device Class 2

MDR Year MDR Reports MDR Events
2021 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 1 1
Defective Device 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Extravasation 1 1
Infiltration into Tissue 1 1
Insufficient Information 1 1

Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II May-06-2022
2 Cardinal Health 200, LLC II Oct-10-2023
3 ROi CPS LLC II Nov-18-2021