Digital Radiography System
FDA 510(k) K827289 · Diagnostic Technology, Inc.
510(k) numberK827289
Submission
- Device name
- Digital Radiography System
- Applicant
- Diagnostic Technology, Inc.
Bedford, MA, US - Received
- March 30, 1982
- Decision date
- April 21, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Diagnostic Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896378 | Lyme-Check(Tm) Test KitLSR · Traditional | 11/05/1991SE |
| K903612 | Ebv/Ea-Check TM Test KitLSE · Traditional | 10/16/1990SE |
| K891542 | Ebna-Check(Tm) Test KitLLM · Traditional | 06/20/1989SE |
| K890819 | Hsv-Check(Tm) Test KitHIS · Traditional | 06/20/1989SE |
| K890639 | Resubmitted Ebv/Igm-Check Test KitLJN · Traditional | 06/20/1989SE |
| K871373 | Ebv-Check(Tm) Test Kit (Igg)GNP · Traditional | 06/25/1987SE |
| K864128 | Chlamydia-Check(Tm) Direct & Culture Confir. KitLJP · Traditional | 04/29/1987SE |
| K863408 | Ebv/Vca-Check(Tm) Antigen SlidesGNP · Traditional | 11/28/1986SE |
| K860586 | PHA-2 Conversion Program for Platelet AnalysisGKL · Traditional | 05/07/1986SE |
| K860166 | Picoscale Blood Cell Counter, Model PS-5GKL · Traditional | 04/04/1986SE |
Questions and answers
When was Digital Radiography System cleared by the FDA?
Digital Radiography System (K827289) received a 510(k) decision of Substantially Equivalent on April 21, 1982, 22 days after the submission was received.