MICSI-PET (K261305): 510(k) cleared for Microstructure Imaging, Inc.
MICSI-PET (K261305): 510(k) cleared for Microstructure Imaging, Inc. (New York): 510(k) cleared for Microstructure Imaging, Inc. Its amount of 144 is above the median of 138 (53rd percentile). Dated 55 days ago, it serves as a historical benchmark. Score 30/100. 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: 144 · 53th percentile of 414 FDAPulse records · 1.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 6 related NY FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261305 |
| Device | MICSI-PET |
| Applicant | Microstructure Imaging, Inc. |
| Specialty / panel | Radiology |
| Product code | KPS |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-20 |
| Decision date | 2026-09-11 |
| Review time (days) | 144 |
| Third-party review | No |
| Applicant location | Brooklyn, NY, US |
| amount percentile | 53th of 414 (median 138, 1.0x median) |
| Peer records CSV (7 NY 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: 2026-09-11
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (NY first): eClinics (K260075) · ZBPro Diagnostic (Version 2.0) (K261580) · Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One- · Class II recall Z-0204-2027 · Class II recall Z-0107-2027 · Browse all by state and category →
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: MICSI-PET (K261305): 510(k) cleared for Microstructure Imaging, Inc. and 7 New York peers
- New York FDAPulse records like this one: 7
- MICSI-PET (K261305): 510(k) cleared for Microstructure Imaging, Inc.'s amount: 53rd percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every New York peer: $1,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 144-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for MICSI-PET (K261305): 510(k) cleared for Microstructure Imaging, Inc. in New York?
MICSI-PET (K261305) by Microstructure Imaging, Inc. was cleared on 2026-09-11 after 144 days of review.
How does MICSI-PET (K261305): 510(k) cleared for Microstructure Imaging, Inc. compare to other New York FDAPulse records?
Its amount of 144 sits in the upper half (53th percentile) of 414 records; the median is 138. It is 55 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
MICSI-PET (K261305) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| MICSI-PET (K261305) | NY | 2026-09-11 |
| 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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