Bella
510(k) K073262
Bella is a Class II device made by Beekley Corp., cleared under FDA 510(k) K073262 on 26 Mar 2008, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073262 | Date26 Mar 2008 | StatusActive |
Official records
- FDA 510(k) database K073262
Recalls
-
- Terminated Z-2080-2012
Imaging artifact can occur on mammogram result
Timeline
- Cleared FDA 510(k) K073262
- Recall initiated FDA recalls Z-2080-2012
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- Withdrawn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
Devices cleared under K073262
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Bella Blankets 310 | 310 | 00815137020230 | — | On the market |
| Bella Blankets 310S | 310S | 00815137021244 | — | On the market |
| Bella Blankets 311 | 311 | 00815137020247 | — | On the market |
| Bella Blankets 311S | 311S | 00815137021251 | — | On the market |
Similar devices
Other devices filed under FDA product code IZH (System, X-Ray, Mammographic).
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- GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM by Medical Marketing Intl., Inc.
- LORAD STEROLOC II by Lorad Corp.
- ISO-MAMMO by Philips Medical Systems (Cleveland), Inc.
- BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH by Bennett X-Ray Corp.
- MODIFIED 650 MAMMOGRAPHY SYSTEM by Lorad, A Hologic Co.
- BREAST LESION LOCALIZATION NEEDLE by Bd Becton Dickinson Vacutainer Systems Preanalytic
- LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM by Hologic, Inc.