Integrity Model 1014284
by Elekta, Ltd.
510(k) K102200
Integrity Model 1014284 is a Class II device made by Elekta, Ltd., cleared under FDA 510(k) K102200 on 4 Nov 2010, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK102200 | Date4 Nov 2010 | StatusActive |
Official records
- FDA 510(k) database K102200
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- FDA applicant
- Elekta , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).
- Clinac 4/100 by Varian Assoc., Inc.
- KLARITY MEDICAL RNB-100 by Klarity Medical Products, LLC
- Varian Unique Single Energy Linear Accelerator by Varian Medical Systems, Oncology Systems
- TrueBeam, TrueBeam STx, Edge, VitalBeam by Varian Medical Systems, Inc.
- Encompass SRS Headframe ; Encompass MR SRS Headframe by Qfix
- Anchored Beacon transponder, Beacon Care Package - Lung by Varian Medical Systems, Inc.
- KLARITY MEDICAL R7800-VBI by Klarity Medical Products, LLC
- Pillow tilt D - Low Density Transparent P10107-227 by IT-V Medizintechnik GmbH
- CDR Systems Precision Patient Positioning System by CDR Systems Inc
- PVS Model 1.0 by Medcom GmbH