FDA 510(k) · Hitachi Medical
K042501: ETG-4000 OPTICAL TOPOGRAPHY SYSTEM (Hitachi Medical Corp.)
Hitachi Medical Corp. received FDA 510(k) K042501 for ETG-4000 OPTICAL TOPOGRAPHY SYSTEM, with a decision date of Oct 12, 2004 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K042501 |
|---|---|
| Pathway | 510(k) |
| Applicant | Hitachi Medical Corp. |
| Device name | ETG-4000 OPTICAL TOPOGRAPHY SYSTEM |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Sep 14, 2004 |
| Decision date | Oct 12, 2004 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The intended use of the ETG-4000 is the measurement of relative levels of cerebral deoxy- hemoglobin and oxyhemoglobin. Prescription Use X AND/OR Over-the-Counter Use (Part 21 CFR 801 Subpart D) (21 CFRSOI SubpartC) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRIf, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices 51O(k) Number OfO~d/ Page I of I
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
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
Later records that cite K042501
- K172492 Optical Topography System ETG-4100 (Hitachi Healthcare Americas, Aug 17, 2018, DQA)
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.