Siemens Medical Solutions USA, Inc.: PMA supplement approved for MAMMOMAT B.brilliant with Tomosynthesis Option
Siemens Medical Solutions USA, Inc. (Mavern, Pennsylvania): PMA supplement approved for MAMMOMAT B.brilliant with Tomosynthesis Option. Dated 126 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 8 published fields of this record are shown below. Locked: 6 related PA FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Siemens Medical Solutions USA, Inc. |
| Product | MAMMOMAT B.brilliant with Tomosynthesis Option |
| Generic / ingredient | Digital breast tomosynthesis |
| Approval | PMA supplement (device change) |
| Application | P140011 S009 |
| Decided | 2026-07-01 |
| Panel / class | Radiology |
| Sponsor location | Mavern, PA |
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| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-07-01
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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Peer benchmark and outreach value: Siemens Medical Solutions USA, Inc. and 7 Pennsylvania peers
- Pennsylvania FdaApprovalPulse records like this one: 7
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Pennsylvania peer: $1,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Siemens Medical Solutions USA, Inc. in Mavern, Pennsylvania?
The FDA approved MAMMOMAT B.brilliant with Tomosynthesis Option (P140011 S009) for Siemens Medical Solutions USA, Inc. on 2026-07-01: PMA supplement (device change).
How does Siemens Medical Solutions USA, Inc. compare to other Pennsylvania FdaApprovalPulse records?
It is 126 days old; check the official source for later updates before acting. Its Score of 30/100 is modest; treat it as background rather than a priority.
Siemens Medical Solutions USA, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | Mavern, PA | 2026-07-01 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Tucson, AZ | 2026-10-23 |
| Cerenovus, Inc. | Miami, FL | 2026-10-23 |
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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.