Igc-Medical Advances, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Igc-Medical Advances, Inc.” (first 2000, latest 2004), across 1 product code in 1 review panel. Median 510(k) review time under this name: 43 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 |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | 7 | 7 |
Review panels
- Radiology (7)
Most recent Igc-Medical Advances, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041185 | TORSO ARRAY COIL, MODEL 558GE-64 | MOS | 2004-05-14 | 8 |
| K040640 | MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL | MOS | 2004-03-22 | 12 |
| K033292 | AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 | MOS | 2003-11-26 | 43 |
| K023848 | MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: | MOS | 2003-02-14 | 87 |
| K003366 | MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL | MOS | 2000-12-22 | 53 |
| K001312 | MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL | MOS | 2000-06-20 | 55 |
| K000589 | MODEL 445SI-64E QUADRATURE WRIST COIL | MOS | 2000-03-14 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Igc-Medical Advances, 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 Igc-Medical Advances, Inc. (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)
Frequently asked questions
How many FDA 510(k) clearances are listed under Igc-Medical Advances, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Igc-Medical Advances, Inc.” (first 2000, latest 2004), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Igc-Medical Advances, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Igc-Medical Advances, Inc. is 43 days.
Which FDA product codes appear under Igc-Medical Advances, Inc.?
The most frequent FDA product codes under this applicant name are MOS (Coil, Magnetic Resonance, Specialty, 7).
Next steps
- See all 7 Igc-Medical Advances, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MOS, Igc-Medical Advances, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.