Radiology-Diagnostic Kit
Regulation 892.1680
0510(k)s in 12 months (0 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in OIP
| Company | 510(k)s | Recalls |
|---|---|---|
| American Contract Systems Inc. | 0 | 2 |
| ROi CPS LLC | 0 | 2 |
| Cardinal Health 200, LLC | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
LKRA40G RADIOLOGY PACK Open, Classified |
OIP | None listed |
| Oct 10, 2023 | Cardinal Health 200, LLC Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile. Open, Classified |
OIP | None listed |
| Mar 22, 2022 | American Contract Systems, Inc. ACS IR - Angio Pack Open, Classified |
OIP | None listed |
| Aug 10, 2021 | ROi CPS LLC REGARD Ultrasound Tray Terminated |
OIP | None listed |
| Aug 10, 2021 | ROi CPS LLC REGARD Stereotactic Tray Terminated |
OIP | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.