EPX-4440HD DIGITAL VIDEO PROCESSOR
FDA 510(k) clearance K140149 · decided 2014-08-22
Clearance details
- K-number
- K140149
- Device name
- EPX-4440HD DIGITAL VIDEO PROCESSOR
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-01-22
- Decision date
- 2014-08-22
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- PEA
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Wayne, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PENTAX Medical Video Processor (EPK-i8020c) (K251127) | Pentax of America, Inc. | 2025-06-03 |
| PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL (K231249) | Pentax of America, Inc. | 2023-07-28 |
| PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL (K190805) | Pentax of America, Inc. | 2019-12-20 |
| PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family (K191282) | Pentax of America, Inc. | 2019-11-08 |
| PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes (K173679) | Pentax of America, Inc. | 2018-07-03 |
| Fuse Endoscopic System with FuseBox Processor (K160275) | Endochoice, Inc. | 2016-08-01 |
| PENTAX Medical EPK-i7010 Video Processor with GI Family (K150618) | Pentax of America, Inc. | 2015-11-24 |
| PENTAX EPK-I5010 VIDEO PROCESSOR (K122470) | Pentax Medical | 2013-04-10 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (P160031/S004) | Fujifilm Medical Systems U.S.A, Inc. | 2023-02-13 |
| ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (P160031/S003) | Fujifilm Medical Systems U.S.A, Inc. | 2020-09-30 |
| Aspire Cristalle Digital Breast Tomosynthesis Option (P160031/S002) | Fujifilm Medical Systems U.S.A, Inc. | 2019-10-25 |
| ASPIRE Cristalle Breast Tomosynthesis System (P160031/S001) | Fujifilm Medical Systems U.S.A, Inc. | 2019-02-08 |
| ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION (P160031) | Fujifilm Medical Systems U.S.A, Inc. | 2017-01-10 |