510(k) K121499
- Device
- FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM
- Applicant
- FUJIFILM MEDICAL SYSTEM U.S.A., INC.
- 510(k) number
- K121499
- Product code
- IZF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-11-20
- Date received
- 2012-05-21
- Regulation
- 892.1740
- Classification name
- System, X-ray, Tomographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATHERINE Y CHOI
- Address
- 419 W. Ave. Stamford CT US 06902 06902
FDA Registration Numbers#
- 9613152
- 3013679558
- 3022810909
- 3009963139
- 3008284470
- 3008496839
- 3001556265
- 3011825597
- 2243057
- 3031503890
- 3014018042
- 3027605321
- 3001722928
- 2126677
- 8020997
- 3023003446
- 3003775006
- 9613445
- 9616047
Source Documents#
Other 510(k) Records For Product Code IZF #
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|---|---|---|---|
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| K252133 | Adaptix Ortho350 | Adaptix Limited | 2025-11-06 |
| K250850 | Nanox.ARC X | Nano-X Imaging , Ltd. | 2025-04-16 |
| K242395 | Nanox.ARC | Nano-X Imaging , Ltd. | 2024-12-04 |
| K222934 | Nanox.ARC | Nano-X Imaging , Ltd. | 2023-04-28 |
| K221949 | Ortho Device, ADAPTIX 3D Orthopedic Imaging System | Pausch Medical GmbH | 2023-01-26 |
| K213081 | CLISIS SYSTEMS, Discovery RF180 | General Medical Merate S.P.A | 2021-10-26 |
| K193262 | DR 600 with Tomosynthesis | Agfa N.V. | 2020-03-09 |
| K183275 | DR 800 with Tomosynthesis | Agfa N.V. | 2019-02-01 |
| K132261 | DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) | Ge Medical Systems, LLC | 2013-11-18 |
| K013620 | MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION | Medstone Intl., Inc. | 2002-01-22 |
| K011290 | PROGNOST ES, MODEL 0302 0000 | Xmar Corp. | 2001-05-30 |
| K973864 | COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO | Pausch Corp. | 1998-06-17 |
| K973834 | CS2000 & CS2000 TOMO | Pausch Corp. | 1998-04-30 |
| K950571 | LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 | Continental X-Ray Corp. | 1995-03-31 |
Legacy Summary#
summary
FDA Review#
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