Inkspace Imaging, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Inkspace Imaging, Inc.” (first 2021, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 24 days. Since 2017 the median was 24 days, against 58 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2021 | 1 | 60 |
| 2022 | 1 | 17 |
| 2023 | 0 | — |
| 2024 | 2 | 52 |
| 2025 | 1 | 24 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Inkspace Imaging, Inc. took a median 24 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 58 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | 5 | 5 |
Review panels
- Radiology (5)
Most recent Inkspace Imaging, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253182 | InkSpace Imaging Small Body Array (SBA12PH30x) | MOS | 2025-10-20 | 24 |
| K243675 | InkSpace Imaging Small Body Array | MOS | 2024-12-20 | 23 |
| K233444 | InkSpace Imaging Small Body Array | MOS | 2024-01-08 | 81 |
| K223487 | InkSpace Imaging Body Array | MOS | 2022-12-08 | 17 |
| K213397 | InkSpace Imaging Pediatric Body Array | MOS | 2021-12-17 | 60 |
Recalls
openFDA lists no recalls under a recalling firm named Inkspace Imaging, 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 Inkspace Imaging, 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 Inkspace Imaging, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Inkspace Imaging, Inc.” (first 2021, latest 2025), 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 Inkspace Imaging, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inkspace Imaging, Inc. is 24 days. Since 2017: 24 days, versus 58 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Inkspace Imaging, Inc.?
The most frequent FDA product codes under this applicant name are MOS (Coil, Magnetic Resonance, Specialty, 5).
Next steps
- See all 5 Inkspace Imaging, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MOS, Inkspace Imaging, 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.