510(k) K111324
- Device
- CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER
- Applicant
- AGFA HEALTHCARE N.V.
- 510(k) number
- K111324
- Product code
- MUE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-12-22
- Date received
- 2011-05-11
- Regulation
- 892.1715
- Classification name
- Full Field Digital, System, X-ray, Mammographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PHIL CUSCUNA
- Address
- 10 S. Academy St. Greenville SC US 29601 29601
FDA Registration Numbers#
- 9613152
- 3005843418
- 3009868110
- 3005810333
- 8043728
- 3009717300
- 3010703925
- 3005172103
- 3003769120
- 3008496839
- 3001556265
- 3015276088
- 3017375271
- 3035950510
- 3004485675
- 3031503890
- 3012127758
- 3001722928
- 3005406110
- 3005496266
- 3004977335
- 3008833258
- 3027339477
- 9680027
- 3005877899
- 3009048384
- 3003768251
- 3006013411
- 3017585294
- 1317307
- 3023003446
- 3003775006
- 3008787461
- 3021059265
- 3009196578
- 3025442726
- 3000126629
- 9611343
- 2433615
Source Documents#
Other 510(k) Records For Product Code MUE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | GE Medical Systems SCS | 2026-03-24 |
| K243420 | HESTIA | Genoray Co., Ltd. | 2025-07-17 |
| K243849 | 2430TCA with Xmaru W | Rayence Co., Ltd. | 2025-03-12 |
| K241113 | VIVIX-M | Vieworks Co., Ltd. | 2025-01-16 |
| K233539 | MAMMOMAT B.brilliant | Siemens Medical Solutions USA, Inc. | 2024-03-27 |
| K220073 | RMF-2000 | DRTECH Corporation | 2023-01-26 |
| K211720 | Planmed Clarity 2D, Planmed Clarify S | Planmed OY | 2022-07-18 |
| K212873 | Aspire Cristalle | Fujifilm Corporation | 2022-05-27 |
| K210151 | Digimamo D | Vmi Tecnologias Ltda | 2022-03-01 |
| K202822 | Helianthus | Metaltronica Spa | 2021-12-15 |
| K211725 | Senographe Pristina | GE Healthcare | 2021-08-06 |
| K211215 | SenoBright HD | GE Healthcare | 2021-06-22 |
| K202902 | 2430MCA with Xmaru W | Rayence Co., Ltd. | 2021-06-21 |
| K192317 | Planmed Clarity 2D and Clarity S | Planmed OY | 2020-10-23 |
| K200424 | Giotto Class (Models - 3000X-YY and 4000X-YY) | Ims Giotto S.P.A. | 2020-06-18 |
Legacy Summary#
summary
FDA Review#
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