Balloon controller PB-30
FDA 510(k) clearance K153483 · decided 2015-12-15
Clearance details
- K-number
- K153483
- Device name
- Balloon controller PB-30
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-12-03
- Decision date
- 2015-12-15
- Days to decision
- 12 days
- Clearance type
- Special
- Product code
- FDF
- 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
+ Add to Predicate Builder ◉ Watch Fujifilm Medical Systems U.S.A
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.
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 |