Mobile Sophie Modification
by Planmed Oy
510(k) K934373
Mobile Sophie Modification is a Class II device made by Planmed Oy, cleared under FDA 510(k) K934373 on 7 Apr 1994, 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 | NumberK934373 | Date7 Apr 1994 | StatusActive |
Official records
- FDA 510(k) database K934373
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IZH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1710
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code IZH (System, X-Ray, Mammographic).
- DIGITIZER, MODEL # 3-000A-1518 by Lorad Medical Systems, Inc.
- EMBRACE by IZI MEDICAL PRODUCTS LLC
- SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096) by Philips Medical Systems (Cleveland), Inc.
- DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM by Elscintec Systems, Ltd.
- RF-1 CIRCUIT by Diagnostic Imaging Specialists Corp.
- ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT by Ausonics Pty, Ltd.
- BIOPSY DIGIT S BIOPSY SL by Giotto USA, LLC
- PATIENT INFORMATION MANAGER (PIM) by Continental X-Ray Corp.
- Biopsy Positioner by FUJIFILM CORPORATION
- BIOPSY-DIGIT by Sitco, Inc.