NTBS-1417, 1436, TBS-1417
FDA 510(k) K946260 · Scott Imaging Intl., Inc.
510(k) numberK946260
Submission
- Device name
- NTBS-1417, 1436, TBS-1417
- Applicant
- Scott Imaging Intl., Inc.
Mobile, AL, US - Received
- December 13, 1994
- Decision date
- March 31, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K953402 | Universix 190IXY · Traditional | Philips Medical Systems (Cleveland), Inc. | 08/11/1995SE |
| K953336 | VRS 3 Wall StandIXY · Traditional | Philips Medical Systems (Cleveland), Inc. | 08/11/1995SE |
| K946114 | Sensori-Motor Rating ScaleIXY · Traditional | Cmed | 04/28/1995SE |
| K930249 | Bc/Wt/PfIXY · Traditional | Tingle X-Ray Products, Inc. | 04/27/1993SE |
| K930230 | Radiographic Wall-Mounted Cassette HolderIXY · Traditional | American Medical Sales, Inc. | 04/27/1993SE |
| K925934 | Wall Bucky Holders Lt. & Rt. Hand, & Center MountIXY · Traditional | Continental X-Ray Corp. | 03/04/1993SE |
| K924445 | BA-4 Wall Bucky and BA-42 Tilting Wall BuckyIXY · Traditional | Control-X, Inc. | 02/19/1993SE |
| K922443 | Vert-X Universal Vertical Bucky StandIXY · Traditional | Afp Imaging Corp. | 10/26/1992SE |
| K915667 | Model H170 Pediatric Chest X-Ray UnitIXY · Traditional | H.L. Lyons Co. | 01/31/1992SE |
| K895034 | Buckys Models YMB-15A, YMB-15B and YMB-15CIXY · Traditional | Yamato Medical Corp. | 11/15/1989SE |
More from Yamato Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K950041 | Sii 360 AprIZO · Traditional | 03/21/1995SE |
| K950040 | Sii 525 AprIZO · Traditional | 03/21/1995SE |
| K946262 | Euro, SCST, Sccft Atlas Radiologic TablesIXQ · Traditional | 02/15/1995SE |
| K946261 | MTS-007, STS-008, SSMTS-010, EURO-40, 72, Super Euro 4072, 5000IYB · Traditional | 02/15/1995SE |
| K945709 | Sii 525 MSKPR · Traditional | 12/14/1994SE |
| K945708 | Sii 360 MSKPR · Traditional | 12/14/1994SE |
Questions and answers
When was NTBS-1417, 1436, TBS-1417 cleared by the FDA?
NTBS-1417, 1436, TBS-1417 (K946260) received a 510(k) decision of Substantially Equivalent on March 31, 1995, 108 days after the submission was received.
What is the product code of K946260?
The FDA product code is IXY – Holder, Radiographic Cassette, Wall-Mounted, a Class I (low risk) device regulated under 21 CFR 892.1880.