LifeJet Printer 400
by Ferrania S.P.A. Stabilimento DI Ferrania
510(k) K011617
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011617 | Date8 Jun 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LMC
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2040
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The LifeJet Printer 400 is a Class II inkjet-based medical image hardcopy device designed for producing color or grayscale prints of digital radiological images. It falls under the nomenclature category of a camera, multi-format radiological device, and is intended for use in radiology settings to generate high-quality printed outputs from medical imaging systems.
This device is supplied as a complete system, including the printer, LifeJet Medical Paper, and LifeJet Medical Ink Jet Cartridges. It operates in clinical radiology environments and is cleared under FDA 510(k) with K-number K011617, classified under the regulatory code 892.2040. The device is non-sterile, single-use consumables (paper and cartridges) are required for operation, and no MRI safety considerations are specified. Storage and handling follow standard medical device protocols.
Questions
AI-generated answers, 19 Sep 2026
What types of medical images can the LifeJet Printer 400 print, and how does it differ from standard office printers?
The LifeJet Printer 400 is specifically designed for producing high-quality color or grayscale prints of digital radiological images—such as X-rays, CT scans, or MRIs—from medical imaging systems. Unlike standard office printers, it is optimized for clinical radiology environments to ensure accurate, durable, and medically compliant output on specialized LifeJet Medical Paper. This distinguishes it from consumer printers, which lack the precision and imaging standards required for diagnostic use.
Are the LifeJet Medical Paper and ink cartridges reusable, or do they need to be replaced after each use?
The LifeJet Medical Paper and ink cartridges are single-use consumables required for operation. They are not designed for reuse, as their performance and sterility may degrade over time, potentially compromising print quality and regulatory compliance. Replacement cartridges and paper must be used for each print job to maintain optimal functionality.
How should the LifeJet Printer 400 be stored, and are there any special handling requirements for its consumables?
The LifeJet Printer 400 follows standard medical device storage protocols, meaning it should be kept in a clean, dry environment protected from extreme temperatures or humidity. The non-sterile printer itself does not require sterile handling, but its single-use consumables (paper and cartridges) should be stored according to manufacturer guidelines to preserve their integrity. Avoid exposure to direct sunlight or moisture, as this could affect print quality or ink performance.
What regulatory pathway was followed for FDA clearance, and how does this affect its use in clinical settings?
The LifeJet Printer 400 was cleared through the FDA 510(k) process (K-number K011617) under the Radiology advisory committee, classified as a Class II device with product code LMC and regulatory number 892.2040. This clearance confirms its substantial equivalence to a predicate device, ensuring it meets FDA standards for safety and effectiveness in radiology settings. Clinicians can rely on this pathway as evidence of its regulatory compliance for producing medical image hardcopies.