Grapefruit USA Inc (GPFT)

[BuyOnDips]

Mugs and AT

These are the reasons the FDA listed for the Domininion not receiving SE at this time.


1. CT emulation images, and a detailed description of the reconstruction algorithms used to create the 3D constructs
2. Sample Images from Predicate Device including soft tissue. Data sets associated with the sample image loops in the submission.
3. Clinical Study: Provide Solid-State X-ray Imager Data
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073780.htm#17
4. Detailed description of cone beam reconstruction.
5. Provide a more detailed description of your reconstruction technique.
6. Software Documentation: sufficient to determine the safety and effectiveness of the device.
7. Device Hazard Analysis.
8. Software Requirements Specifications(SRS)
9. Software Design Specification (SDS)
10. Traceability Analysis
11. Development Environment Analysis
12. Programmable Electrical Medical Systems Verification and Validation Documentation
13. Revision Level History: history of software revisions generated during the course of product development.
14. Off-the-Shelf Software: Please provide basic documentation for off-the-shelf software used in your device.
15. Vibration analysis.
16. Overheating analysis.
17. Lateral Patient Access analysis.
18. User Sync Detector Mode: data evidence from supplier and testing.
19. User's Manual: Deficiency: description of all post-processing features of this device.
20. Over-the-Counter Use: identify a predicate device for over the counter use. Demonstrate that your device meets the requirements of 21 CFR § 801 Subpart B (Labeling Requirements for Over-the-Counter Devices).
21. Electronic Copy: provided in accordance with the guidelines.