FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FS IV MINI C-ARM SYSTEM
K Number: K974058
·
Decision Jan 12, 1998
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
116
Review Days
77
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FS IV MINI C-ARM SYSTEM
- K Number
- K974058
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hologic, Inc.
- Date Received
- October 27, 1997
- Decision Date
- January 12, 1998
- Product Code
- JAA
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAA), ordered by most recent decision date.
Nexus DRF Digital X-ray Imaging System
FDA 510(k)
FDA Class 2
·Radiology
Insight Enhanced DRF (EN-1002-01)
FDA 510(k)
FDA Class 2
·Radiology
Soteria E-View
FDA 510(k)
FDA Class 2
·Radiology
Adora DRFi (04550010)
FDA 510(k)
FDA Class 2
·Radiology
TRIDENT Mobile Fluoroscopy System
FDA 510(k)
FDA Class 2
·Radiology
ProxiDiagnost N90 / Precision CRF (706110, 706400)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Hologic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253634 | CoolSeal Generator® (CSL-200-90) | Jun 17, 2026 | Substantially Equivalent |
| K251993 | Panther Fusion GI Expanded Bacterial Assay | Sep 25, 2025 | Substantially Equivalent |
| K243341 | Genius AI Detection 2.0 | Jul 31, 2025 | Substantially Equivalent |
| K243396 | Aptima SARS-CoV-2 Assay | Feb 13, 2025 | Substantially Equivalent |
| K243935 | Aptima CMV Quant Assay | Jan 17, 2025 | Substantially Equivalent |
| K243345 | Aptima BV Assay; Aptima CV/TV Assay | Nov 25, 2024 | Substantially Equivalent |
| K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | Nov 15, 2024 | Substantially Equivalent |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) | Jul 25, 2024 | Substantially Equivalent |
| K233352 | Aptima HCV Quant Dx Assay | Jul 24, 2024 | Substantially Equivalent |
| K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Jul 18, 2024 | Substantially Equivalent |