Perspectum, Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Perspectum, Ltd.” (first 2020, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 92 days. Since 2017 the median was 92 days, against 119 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 |
|---|---|---|
| 2020 | 1 | 60 |
| 2021 | 1 | 67 |
| 2022 | 2 | 271 |
| 2023 | 1 | 29 |
| 2024 | 2 | 92 |
| 2025 | 0 | — |
| 2026 | 1 | 159 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Perspectum, Ltd. took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 5 | 5 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
Review panels
- Radiology (8)
Most recent Perspectum, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253413 | LiverMultiScan (v6.0) | LNH | 2026-03-09 | 159 |
| K241925 | VitruvianScan (v1.0) | LNH | 2024-10-02 | 93 |
| K233930 | MRCP+ version 2 (MRCP+ v2) | LLZ | 2024-03-13 | 90 |
| K230294 | CoverScan (CoverScan v1.1) | LLZ | 2023-03-03 | 29 |
| K213960 | LiverMultiScan v5 (LMSv5) | LNH | 2022-09-06 | 263 |
| K212565 | CoverScan v1 | LLZ | 2022-05-19 | 279 |
| K203280 | Hepatica v1 (Hepatica v1.0.0) | LNH | 2021-01-12 | 67 |
| K202170 | LiverMultiScan | LNH | 2020-10-02 | 60 |
Recalls
openFDA lists no recalls under a recalling firm named Perspectum, Ltd..
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.
Device clinical trials
An industry sponsor named Perspectum, Ltd. is the lead sponsor of 10 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04597710: Precision Medicine for Liver Tumours With Quantitative Magnetic Resonance Imaging and Whole Genome Sequencing (Active not recruiting, started 2021-02-18)
- NCT04341246: Characterization and Technical Evaluation of cT1 for NASH (CATE-NASH) (Completed, started 2021-01-28)
- NCT04336618: Multi-Parametric MRI Assessment of the Liver in the Dallas-FortWorth Metroplex Population (Completed, started 2020-08-03)
- NCT04336800: Multi-Parametric MRI Assessment of the Liver in Diabetic Volunteers (Partners Registry) (Completed, started 2020-04-01)
- NCT03979053: Quantitative Magnetic Resonance Imaging to Aid Clinical Decision Making in Autoimmune Hepatitis. (Completed, started 2019-06-26)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Perspectum, Ltd. (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.
- Perspectum Diagnostics, Ltd. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Perspectum, Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Perspectum, Ltd.” (first 2020, latest 2026), across 2 product codes 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 Perspectum, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Perspectum, Ltd. is 92 days. Since 2017: 92 days, versus 119 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Perspectum, Ltd.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 5); LLZ (System, Image Processing, Radiological, 3).
Next steps
- See all 8 Perspectum, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Perspectum, Ltd.'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.