BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125): 510(k) cleared for Samsung HME America, Inc., dba NeuroLogica Corp.
BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125): 510(k) cleared for Samsung HME America, Inc., dba NeuroLogica Corp. (Massachusetts): 510(k) cleared for Samsung HME America, Inc., dba NeuroLogica Corp. Its amount of 169 is above the median of 138 (61st percentile). Dated 44 days ago, it serves as a historical benchmark. Score 48/100. As of 2026-11-04, 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: 169 · 61th percentile of 414 FDAPulse records · 1.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 40 related MA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261125 |
| Device | BodyTom 64 (NL4100); OmniTom Elite (NL5000) |
| Applicant | Samsung HME America, Inc., dba NeuroLogica Corp. |
| Specialty / panel | Radiology |
| Product code | JAK |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-06 |
| Decision date | 2026-09-22 |
| Review time (days) | 169 |
| Third-party review | No |
| Applicant location | Danvers, MA, US |
| amount percentile | 61th of 414 (median 138, 1.2x median) |
| Peer records CSV (41 MA records) | 🔒 Click to unlock → |
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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: 2026-09-22
- Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125): 510(k) cleared for Samsung HME America, Inc., dba NeuroLogica Corp. and 41 Massachusetts peers
- Massachusetts FDAPulse records like this one: 41
- BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125): 510(k) cleared for Samsung HME America, Inc., dba NeuroLogica Corp.'s amount: 61st percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Massachusetts peer: $8,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 169-day review, longer than typical.
- Posted 44 days ago.
What is the FDAPulse record for BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125): 510(k) cleared for Samsung HME America, Inc., dba NeuroLogica Corp. in Massachusetts?
BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125) by Samsung HME America, Inc., dba NeuroLogica Corp. was cleared on 2026-09-22 after 169 days of review.
How does BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125): 510(k) cleared for Samsung HME America, Inc., dba NeuroLogica Corp. compare to other Massachusetts FDAPulse records?
Its amount of 169 sits in the upper half (61th percentile) of 414 records; the median is 138. It is 44 days old, still within a typical 45-day follow-up window.
BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125) | MA | 2026-09-22 |
| 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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