Digital Diagnostic X-Ray System, Models Mak 1500, Mak 2000 and Mak 3000
FDA 510(k) K082798 · Medicatech USA
510(k) numberK082798
Submission
- Device name
- Digital Diagnostic X-Ray System, Models Mak 1500, Mak 2000 and Mak 3000
- Applicant
- Medicatech USA
Deer Field, IL, US - Received
- September 23, 2008
- Decision date
- October 28, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K143257 | KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic SystemKPR · Traditional | 02/06/2015SE |
| K130377 | Krystalrad New Seriesdigital Radiographic Portable Retrofit SystemMQB · Special | 05/17/2013SE |
| K112132 | Krystalrad 660 Digital Radiographic Portable Retrofit SystemMQB · Traditional | 11/18/2011SE |
| K102285 | Krystalrad (ATAL8)KPR · Traditional | 01/03/2011SE |
| K102284 | Krystalrad 560 (Flaatz 560)KPR · Traditional | 01/03/2011SE |
| K080582 | Medicatech, Model DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FaKPR · Traditional | 05/15/2008SE |
Questions and answers
When was Digital Diagnostic X-Ray System, Models Mak 1500, Mak 2000 and Mak 3000 cleared by the FDA?
Digital Diagnostic X-Ray System, Models Mak 1500, Mak 2000 and Mak 3000 (K082798) received a 510(k) decision of Substantially Equivalent on October 28, 2008, 35 days after the submission was received.
What is the product code of K082798?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.