ASPIRE Cristalle Breast Tomosynthesis System
FDA premarket approval P160031/S001 · decided 2019-02-08
Approval details
- PMA number
- P160031
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ASPIRE Cristalle Breast Tomosynthesis System
- Generic name
- Digital breast tomosynthesis
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
- Date received
- 2018-10-23
- Decision date
- 2019-02-08
- Days to decision
- 108 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Stamford, CT
- Statement
- Approval for the implementation of the synthesized 2D (S-View) image, changing the image processing in DBT reconstruction to iterative super-resolution reconstruction (ISR), applying new image processing, Dynamic Visualization II for mammography (DVIIm), to DBT and synthesized 2D images, and related changes in the indications for use (IFU).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FUJIFILM Bronchoscope Model EB-530P (K171291) | Fujifilm Medical Systems U.S.A, Inc. | 2018-01-19 |
| FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M (K171207) | Fujifilm Medical Systems U.S.A, Inc. | 2018-01-11 |
| ASPIRE Cristalle (K173132) | Fujifilm Medical Systems U.S.A, Inc. | 2017-10-27 |
| ASPIRE Bellus II (K171463) | Fujifilm Medical Systems U.S.A, Inc. | 2017-09-29 |
| Fujifilm Duodenoscope Model ED-530XT (K152257) | Fujifilm Medical Systems U.S.A, Inc. | 2017-07-21 |
| Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) (K163624) | Fujifilm Medical Systems U.S.A, Inc. | 2017-06-30 |
| FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR (K162749) | Fujifilm Medical Systems U.S.A, Inc. | 2017-06-15 |
| Fujifilm Diathermic Slitter (FlushKnife) (K171096) | Fujifilm Medical Systems U.S.A, Inc. | 2017-05-09 |