Flaatz 760
by Drtech Corp.
510(k) K111655
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK111655 | Date30 Nov 2011 | StatusActive |
Official records
- FDA 510(k) database K111655
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KPR
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Flaatz 760 is a stationary X-ray system flat panel detector, designed for high-volume radiography applications. It features a radiography flat panel detector with advanced temperature stability and uniform coating technology to ensure consistent image quality even after extensive use.
This device is intended for use in radiology settings and is supplied as a reusable, non-sterile medical device. It is classified as a Class II device under FDA regulations (21 CFR 892.1680) and holds a Special 510(k) clearance (K111655) with a decision date of November 30, 2011. The device is MRI-unsafe and requires proper storage and handling as specified by the manufacturer.
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