FDA 510(k) for PACS (Picture Archiving & Communication System)

PACS (Picture Archiving & Communication System) is a Class II Medical Device (product code LLZ) requiring FDA 510(k) clearance before marketing in the USA. LMG provides expert 510(k) consulting for pacs manufacturers worldwide.

Class II Medical Device510(k) ClearanceSubstantial EquivalenceSince 2009

510(k) Requirements for PACS (Picture Archiving & Communication System)

The FDA 510(k) requirements for Picture Archiving and Communication Systems (PACS) depend on the intended use and the specific features of the device. Generally, a 510(k) submission is required for a PACS that incorporates new technology, significantly modifies an existing device, or is intended for a new indication for use.

Here are some key points to consider when preparing a 510(k) submission for a PACS:

Device Description: The submission should include a detailed description of the PACS, including its hardware and software components, and its intended use.

Predicate Device: The submission should identify a legally marketed predicate device that is substantially equivalent to the PACS being submitted.

Performance Testing: The submission should include performance testing data that demonstrate the safety and effectiveness of the device. This may include testing for image quality, accuracy, reliability, and usability.

Risk Analysis: The submission should include a risk analysis that identifies potential hazards associated with the use of the PACS, and describes how those risks will be mitigated.

Labeling: The submission should include labeling that meets FDA requirements, including instructions for use, warnings, and precautions.

Clinical Data: The submission may need to include clinical data, such as studies or case reports, to support the safety and effectiveness of the device.

Quality System: The submission should include documentation of the PACS manufacturer’s quality system, including procedures for design, testing, and manufacturing.

It’s important to note that the 510(k) requirements are subject to change, and it’s essential to consult an experienced FDA consultant for the most up-to-date information and guidance.

LMG Provides assistance to medical imaging manufacturers in FDA registration, 510k clearance, device listing, and US FDA Agent requirements. FDA 510K Clearance for PACS is public information; you can search for it on the FDA website. Below are examples of PACS 510k clearances

Our experienced consultants can help you to comply with FDA requirements. Our expertise includes

Prepare PACS 510k notification
Submission of PACS 510k notification
FDA Agent service for 510k submission
Guidance in test requirements
Register your establishment with FDA
List your PACS with FDA.

FDA 510(k) for PACS — FAQs

Common questions about FDA 510(k) clearance for pacs (picture archiving & communication system).

What is the FDA product code for PACS?

PACS systems are typically product code LLZ (Class II).

Does PACS require 510(k) clearance?

Yes. PACS used for diagnostic imaging review is a Class II medical device requiring 510(k) clearance.

Need a PACS 510(k) Consultant?

LMG provides expert 510(k) consulting for pacs (picture archiving & communication system) manufacturers — from predicate device selection through clearance.

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