Class Class II
Affirm 800 (K243077)
Description
Affirm 800 by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery), an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243077
Clearance Date2025-06-27
Clearance TypeTraditional
Product CodeIZI
Regulation Number892.1600
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243077
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Affirm 800 (K243077) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202391 | DIR 800 | Aesculap, Inc. | 2021 |
Trace the full predicate network for K243077
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.