FDA 510(k) · Hitachi Healthcare Americas
K172492: Optical Topography System ETG-4100 (Hitachi Healthcare Americas)
Hitachi Healthcare Americas received FDA 510(k) K172492 for Optical Topography System ETG-4100, with a decision date of Aug 17, 2018 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K172492 |
|---|---|
| Pathway | 510(k) |
| Applicant | Hitachi Healthcare Americas |
| Device name | Optical Topography System ETG-4100 |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Aug 17, 2017 |
| Decision date | Aug 17, 2018 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The intended use of the ETG-4100 is the measurement of relative levels of cerebral deoxyhemoglobin and oxyhemoglobin.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K042501 ETG-4000 OPTICAL TOPOGRAPHY SYSTEM (Hitachi Medical)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DQA is "Oximeter", class 2, 21 CFR 870.2700.
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Finger PPG. These are heuristics, not FDA fields.