syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc.
syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc. (Tennessee): 510(k) cleared for Siemens Medical Solutions USA, Inc. Its amount of 260 is above the median of 138 (82nd percentile). Dated 41 days ago, it serves as a historical benchmark. Score 61/100. 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: 260 · 82th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 8 related TN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260055 |
| Device | syngo.CT Brain Quantification |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Specialty / panel | Radiology |
| Product code | QIH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-08 |
| Decision date | 2026-09-25 |
| Review time (days) | 260 |
| Third-party review | No |
| Applicant location | Knoxville, TN, US |
| amount percentile | 82th of 414 (median 138, 1.9x 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: 2026-09-25
- Data refreshed: 2026-11-04
- 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: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc. and 9 Tennessee peers
- Tennessee FDAPulse records like this one: 9
- syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc.'s amount: 82nd percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Tennessee peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 260-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 41 days ago.
What is the FDAPulse record for syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc. in Tennessee?
syngo.CT Brain Quantification (K260055) by Siemens Medical Solutions USA, Inc. was cleared on 2026-09-25 after 260 days of review.
How does syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc. compare to other Tennessee FDAPulse records?
Its amount of 260 sits in the upper half (82th percentile) of 414 records; the median is 138. It is 41 days old, still within a typical 45-day follow-up window.
syngo.CT Brain Quantification (K260055) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| syngo.CT Brain Quantification (K260055) | TN | 2026-09-25 |
| 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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