Lung Guidance (K261042): 510(k) cleared for GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Lung Guidance (K261042): 510(k) cleared for GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (Wisconsin): 510(k) cleared for GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. Its amount of 185 is above the median of 138 (65th percentile). Dated 33 days ago, it serves as a historical benchmark. Score 48/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 185 · 65th percentile of 414 FDAPulse records · 1.3x the median
Free preview: all 14 published fields of this record are shown below. Locked: 3 related WI FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261042 |
| Device | Lung Guidance |
| Applicant | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC |
| Specialty / panel | Radiology |
| Product code | QJU |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-03-31 |
| Decision date | 2026-10-02 |
| Review time (days) | 185 |
| Third-party review | No |
| Applicant location | Waukesha, WI, US |
| amount percentile | 65th of 414 (median 138, 1.3x median) |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-02
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Lung Guidance (K261042): 510(k) cleared for GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC and 4 Wisconsin peers
- Wisconsin FDAPulse records like this one: 4
- Lung Guidance (K261042): 510(k) cleared for GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC's amount: 65th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Wisconsin peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 185-day review, longer than typical.
- Posted 33 days ago.
What is the FDAPulse record for Lung Guidance (K261042): 510(k) cleared for GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC in Wisconsin?
Lung Guidance (K261042) by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC was cleared on 2026-10-02 after 185 days of review.
How does Lung Guidance (K261042): 510(k) cleared for GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC compare to other Wisconsin FDAPulse records?
Its amount of 185 sits in the upper half (65th percentile) of 414 records; the median is 138. It is 33 days old, still within a typical 45-day follow-up window.
Lung Guidance (K261042) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Lung Guidance (K261042) | WI | 2026-10-02 |
| VenusCT (K260510) | CA | 2026-10-19 |
| AVIEW Aorta Metrics (K260391) | KR | 2026-10-16 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
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