Lifejet Video Link
FDA 510(k) K013395 · Ferrania S.P.A.
510(k) numberK013395
Submission
- Device name
- Lifejet Video Link
- Applicant
- Ferrania S.P.A.
Ferrania, Savona, IT - Received
- October 15, 2001
- Decision date
- October 30, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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|---|---|---|---|
| K132183 | Dicom VideoLMA · Traditional | Bar Code Computer, Ltd. | 10/03/2013SE |
| K130636 | Teleradpro Edge; Teleradpro Edge Hd-CcdLMA · Traditional | Vidar Systems Corp. | 06/07/2013SE |
| K130406 | Diagnosticpro EdgeLMA · Traditional | Vidar Systems Corp. | 04/29/2013SE |
| K102476 | TeleradproLMA · Special | Vidar Systems Corp. | 10/07/2010SE |
| K093809 | Vidar Dental Film DigitizerLMA · Traditional | Vidar Systems Corp. | 01/07/2010SE |
| K091288 | MEDI-6000 Medical Image DigitizerLMA · Traditional | Microtek International, Inc. | 08/14/2009SE |
| K063424 | Film Digitzer, Model 2908 Mammo ProLMA · Traditional | Array Corp. | 12/21/2006SE |
| K042484 | Nai Tech Products Medical Digital RecorderLMA · Traditional | Nai Technology Products | 10/20/2004SE |
| K033637 | Medical Image Digitizer, Model 2908LMA · Special | Array Corp. | 12/17/2003SE |
| K032022 | Digital ImagerLMA · Traditional | Pyramid Medical, Inc. | 09/02/2003SE |
More from Pyramid Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K012373 | Liferay WL Cassette, Liferay KW CassetteIXA · Traditional | 08/09/2001SE |
Questions and answers
When was Lifejet Video Link cleared by the FDA?
Lifejet Video Link (K013395) received a 510(k) decision of Substantially Equivalent on October 30, 2001, 15 days after the submission was received.
What is the product code of K013395?
The FDA product code is LMA – Digitizer, Image, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2030.