FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY
K Number: K983313
·
Decision Dec 11, 1998
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
175
Applicant Total
94
Review Days
81
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
- ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY
- K Number
- K983313
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elscint, Inc.
- Date Received
- September 21, 1998
- Decision Date
- December 11, 1998
- Product Code
- IZH
- 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 |
|---|---|---|---|
| IZH | System, X-Ray, Mammographic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZH), ordered by most recent decision date.
SMART FINDER
FDA 510(k)
FDA Class 2
·Radiology
Affirm Contrast Biopsy
FDA 510(k)
FDA Class 2
·Radiology
Biopsy Positioner
FDA 510(k)
FDA Class 2
·Radiology
Affirm Lateral Arm Upright Biopsy Accessory
FDA 510(k)
FDA Class 2
·Radiology
Comfort Cover
FDA 510(k)
FDA Class 2
·Radiology
Affirm Prone Biopsy System
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Elscint, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K982060 | VOLUMAX CT IMAGING SYSTEM | Sep 2, 1998 | Substantially Equivalent |
| K974344 | CT SCOPE | Jun 3, 1998 | Substantially Equivalent |
| K980306 | GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP | Apr 2, 1998 | Substantially Equivalent |
| K974614 | GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 | Mar 4, 1998 | Substantially Equivalent |
| K972592 | 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) | Sep 15, 1997 | Substantially Equivalent |
| K970680 | GLORY | Jun 20, 1997 | Substantially Equivalent |
| K965044 | GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 | Jun 16, 1997 | Substantially Equivalent |
| K970980 | CARDIAC SCORING FOR CT SCANNERS | May 29, 1997 | Substantially Equivalent |
| K970005 | GYREX 2T-PRESTIGE | Mar 28, 1997 | Substantially Equivalent |
| K964583 | XRT-7.0 | Jan 17, 1997 | Substantially Equivalent |