CHENOWETH-FRANK RADIOPATHOLOGICAL GRID
FDA 510(k) clearance K933754 · decided 1993-09-20
Clearance details
- K-number
- K933754
- Device name
- CHENOWETH-FRANK RADIOPATHOLOGICAL GRID
- Applicant
- Cook, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-03
- Decision date
- 1993-09-20
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- IZH
- Device class
- 2
- Regulation number
- 892.1710
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Ontario L4a 7x5, CA
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cook
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SMART FINDER (K203509) | Ims Giotto S.P.A. | 2021-07-14 |
| Affirm Contrast Biopsy (K202294) | Hologic, Inc. | 2020-10-05 |
| Biopsy Positioner (K191495) | Fujifilm Corporation | 2019-07-03 |
| Affirm Lateral Arm Upright Biopsy Accessory (K161575) | Hologic | 2016-08-10 |
| Comfort Cover (K161920) | Precision Dynamics Corporation | 2016-07-15 |
| Affirm Prone Biopsy System (K153486) | Hologic, Inc. | 2016-04-01 |
| MammoGRIP (K152038) | Women'S Imaging Solutions Enterprises, LLC | 2015-12-22 |
| AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (K122836) | Lorad, A Hologic Co. | 2013-01-11 |
| SPECBOARD JR. (K123414) | Macbrud Corp., Medical Division | 2013-01-11 |
| BIOPSY DIGIT S BIOPSY SL (K113607) | Giotto USA, LLC | 2012-08-10 |
| BIOPSY POSITIONER (K113284) | Fuji Film Medical Systems | 2012-03-07 |
| AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (K103512) | Hologic, Inc. | 2011-01-07 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Zenith® Iliac Branch (P020018/S064) | Cook, Inc. | 2025-05-30 |
| ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM (P020018/S065) | Cook, Inc. | 2025-04-09 |
| Zenith Fenestrated AAA Endovascular Graft (P020018/S063) | Cook, Inc. | 2024-04-29 |
| Zenith® Fenestrated AAA Endovascular Graft, Zenith® Flex AAA Endovascular System (P020018/S061) | Cook, Inc. | 2023-12-14 |
| Zenith® Fenestrated AAA Endovascular Graft (ZFEN), Zenith® Flex AAA Endovascular System (P020018/S062) | Cook, Inc. | 2023-12-13 |
| Zenith Fenestrated AAA Endovascular Graft (P020018/S060) | Cook, Inc. | 2022-01-20 |
| Zenith AAA Endovascular Graft (P020018/S059) | Cook, Inc. | 2020-10-08 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S055) | Cook, Inc. | 2018-10-10 |