Tomtec Imaging Systems GmbH: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Tomtec Imaging Systems GmbH” (first 1995, latest 2022), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 56 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 | 2 | 86 |
| 2013 | 1 | 104 |
| 2014 | 0 | — |
| 2015 | 1 | 24 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 59 |
| 2021 | 0 | — |
| 2022 | 1 | 59 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tomtec Imaging Systems GmbH took a median 59 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 13 | 13 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 | 5 |
| DQK | Computer, Diagnostic, Programmable | 3 | 3 |
| LMB | Device, Digital Image Storage, Radiological | 1 | 1 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
Review panels
- Radiology (20)
- Cardiovascular (3)
Most recent Tomtec Imaging Systems GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213544 | TOMTEC-ARENA | QIH | 2022-01-06 | 59 |
| K201632 | TOMTEC-ARENA | LLZ | 2020-08-14 | 59 |
| K150122 | TOMTEC-ARENA TTA2 | LLZ | 2015-02-13 | 24 |
| K132544 | TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA | LLZ | 2013-11-25 | 104 |
| K122289 | IMAGE-COM 5.0 | LLZ | 2012-10-24 | 86 |
| K120135 | 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 | LLZ | 2012-04-13 | 87 |
| K110746 | 4D LV-ANALYSIS 3.0 | DQK | 2011-05-24 | 68 |
| K110667 | IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS | LLZ | 2011-04-08 | 30 |
| K110595 | 4D SONO-SCAN 1.0 | LLZ | 2011-04-07 | 36 |
| K103782 | 4D MV-ASSESSMENT 2.0 | DQK | 2011-01-27 | 31 |
13 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-09-23.
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.
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.
- Tomtec (2 510(k)s)
- Tomtec Tomographic Technologies GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tomtec Imaging Systems GmbH?
FDA lists 23 510(k) clearances under the applicant name “Tomtec Imaging Systems GmbH” (first 1995, latest 2022), across 5 product codes in 2 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 Tomtec Imaging Systems GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tomtec Imaging Systems GmbH is 56 days.
Which FDA product codes appear under Tomtec Imaging Systems GmbH?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 13); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 5); DQK (Computer, Diagnostic, Programmable, 3).
Next steps
- See all 23 Tomtec Imaging Systems GmbH clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Tomtec Imaging Systems GmbH'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.