Diasonics, Inc.: FDA filings under this applicant name
FDA lists 42 510(k) clearances under the applicant name “Diasonics, Inc.” (first 1978, latest 1997), across 14 product codes in 6 review panels. Median 510(k) review time under this name: 78 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 11 | 11 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 10 | 10 |
| ITX | Transducer, Ultrasonic, Diagnostic | 8 | 8 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 2 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 2 |
| DSF | Recorder, Paper Chart | 1 | 1 |
| DXK | Echocardiograph | 1 | 1 |
| FCI | Punch, Biopsy | 1 | 1 |
| GXW | Echoencephalograph | 1 | 1 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
Plus 4 more product codes.
Review panels
- Radiology (32)
- Cardiovascular (4)
- Neurology (2)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
- Orthopedic (1)
Most recent Diasonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962662 | VINGMED SOUND COLOR FLOW MAPPING SYSTEM | IYO | 1997-01-02 | 178 |
| K924079 | CFM-800 COLOR FLOW MAPPING SYSTEM | IYO | 1993-09-28 | 411 |
| K911435 | CPA/3.5 MHZ PROBE | ITX | 1992-09-11 | 528 |
| K905200 | SACA, 3.5 MHZ PROBE | ITX | 1992-04-02 | 499 |
| K903562 | CW DOPPLER 2.25 MHZ PROBE | ITX | 1992-03-02 | 573 |
| K903984 | CW DOPPLER/4.5 MHZ | ITX | 1991-06-14 | 289 |
| K896637 | ACCESS(TM), SOFTWARE RELEASE 4.11P | LPH | 1990-01-22 | 59 |
| K893518 | MT/S SOFTWARE RELEASE 5.0. | LNH | 1989-10-27 | 172 |
| K894290 | ACCESS TM | LNH | 1989-09-07 | 76 |
| K893881 | ACCESS TM | LNH | 1989-06-23 | 28 |
32 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Diasonics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Diasonics, Inc. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Diasonics Ultrasound (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Diasonics, Inc.?
FDA lists 42 510(k) clearances under the applicant name “Diasonics, Inc.” (first 1978, latest 1997), across 14 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Diasonics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diasonics, Inc. is 78 days.
Which FDA product codes appear under Diasonics, Inc.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 11); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 10); ITX (Transducer, Ultrasonic, Diagnostic, 8).
Next steps
- See all 42 Diasonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Diasonics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.