Film Digitzer, Model 2908 Mammo Pro
FDA 510(k) K063424 · Array Corp.
510(k) numberK063424
Submission
- Device name
- Film Digitzer, Model 2908 Mammo Pro
- Applicant
- Array Corp.
Tokyo, JP - Received
- November 13, 2006
- Decision date
- December 21, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K091288 | MEDI-6000 Medical Image DigitizerLMA · Traditional | Microtek International, Inc. | 08/14/2009SE |
| 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 |
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Questions and answers
When was Film Digitzer, Model 2908 Mammo Pro cleared by the FDA?
Film Digitzer, Model 2908 Mammo Pro (K063424) received a 510(k) decision of Substantially Equivalent on December 21, 2006, 38 days after the submission was received.
What is the product code of K063424?
The FDA product code is LMA – Digitizer, Image, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2030.