Nai Tech Products Medical Digital Recorder
FDA 510(k) K042484 · Nai Technology Products
510(k) numberK042484
Submission
- Device name
- Nai Tech Products Medical Digital Recorder
- Applicant
- Nai Technology Products
Upland, CA, US - Received
- September 13, 2004
- Decision date
- October 20, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code LMA
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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 |
| K033637 | Medical Image Digitizer, Model 2908LMA · Special | Array Corp. | 12/17/2003SE |
| K032022 | Digital ImagerLMA · Traditional | Pyramid Medical, Inc. | 09/02/2003SE |
| K022810 | Cobrascan CR-1 FilmlessLMA · Traditional | Radiographic Digital Imaging, Inc. | 10/11/2002SE |
Questions and answers
When was Nai Tech Products Medical Digital Recorder cleared by the FDA?
Nai Tech Products Medical Digital Recorder (K042484) received a 510(k) decision of Substantially Equivalent on October 20, 2004, 37 days after the submission was received.
What is the product code of K042484?
The FDA product code is LMA – Digitizer, Image, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2030.