VARICAM
FDA 510(k) clearance K953801 · decided 1995-11-22
Clearance details
- K-number
- K953801
- Device name
- VARICAM
- Applicant
- Elscint, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-11
- Decision date
- 1995-11-22
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hackensack, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System recall (Z-2098-2025) | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | 2025-07-08 |
| GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) recall (Z-0900-2025) | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | 2025-01-10 |
| GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all config recall (Z-1279-2015) | GE Healthcare | 2015-03-13 |
| GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Qua recall (Z-1788-2013) | GE Healthcare, LLC | 2013-07-24 |
| Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM00108 recall (Z-0012-05) | General Electric Med Systems LLC | 2004-10-07 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GYREX (P840007/S003) | Elscint, Inc. | 1988-04-26 |
| GYREX, MODELS S3500 & S5000 (P840007/S002) | Elscint, Inc. | 1987-10-08 |
| GYREX, MODELS S3500 & S5000 (P840007/S001) | Elscint, Inc. | 1987-04-02 |