Diagnostic Pro, Model 12772, VXR-16, Model 13020, VXR-16 Dosimetry Pro, Model 13019
FDA 510(k) K993599 · Vidar Systems Corp.
510(k) numberK993599
Submission
- Device name
- Diagnostic Pro, Model 12772, VXR-16, Model 13020, VXR-16 Dosimetry Pro, Model 13019
- Applicant
- Vidar Systems Corp.
Herndon, VA, US - Received
- October 25, 1999
- Decision date
- January 18, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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 |
|---|---|---|
| K130636 | Teleradpro Edge; Teleradpro Edge Hd-CcdLMA · Traditional | 06/07/2013SE |
| K130406 | Diagnosticpro EdgeLMA · Traditional | 04/29/2013SE |
| K102476 | TeleradproLMA · Special | 10/07/2010SE |
| K093809 | Vidar Dental Film DigitizerLMA · Traditional | 01/07/2010SE |
| K071193 | Vidar Vision 3000 and 4000 X-Ray SystemsMQB · Special | 05/30/2007SE |
| K070563 | Vidar Vision 2000MQB · Traditional | 03/16/2007SE |
| K024171 | Vidar Bone Track System SoftwareJAK · Traditional | 03/04/2003SE |
| K011049 | ExpresssuiteLMA · Traditional | 10/01/2001SE |
| K993598 | Mammography Pro, Model 13017, Diagnostic Pro W/ Mammography Option, Model 13205LMA · Traditional | 01/20/2000SE |
| K993597 | PLLL, Teleradpro, Model 12714/12715, VXR-12 Plus, Model 8619/9617LMA · Traditional | 12/15/1999SE |
Questions and answers
When was Diagnostic Pro, Model 12772, VXR-16, Model 13020, VXR-16 Dosimetry Pro, Model 13019 cleared by the FDA?
Diagnostic Pro, Model 12772, VXR-16, Model 13020, VXR-16 Dosimetry Pro, Model 13019 (K993599) received a 510(k) decision of Substantially Equivalent on January 18, 2000, 85 days after the submission was received.
What is the product code of K993599?
The FDA product code is LMA – Digitizer, Image, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2030.